Job Title: Research Development & Sciences - Clinical Operations Staff

 Job Description: The Manager, Clinical Trial Disclosure and Transparency is responsible for executing Companies disclosure and transparency activities as directed, including the redaction and anonymization of clinical trial documents required for public disclosure in compliance with regulatory requirements and Companies policy and processes. This role will partner with internal stakeholders and external vendors for the planning, initiation and delivery of redacted/anonymized documents required for EU Clinical Trial Applications according to the EU Clinical Trial Regulation 536/2014 and Health Authority transparency submissions (eg EMA Policy 0070, Health Canada PRCI).

The incumbent will also contribute to the development and maintenance of procedures and standards that will support current and future global clinical trial disclosure requirements.

This role operates within a global matrix organization and is responsible for active collaboration with teams and stakeholders within R&D including Global Regulatory Affairs, Clinical Development, Medical Writing, Biostatistics, Project Management, Product Development and Intellectual Property.

Role reports into the Director, Office of the CMO, and is supervised on a day-to-day basis by the Data Transparency Lead.

Work hours are flexible, and role is 100% remote and supports a global team/function. Assignment manager is located in Australia. Some interaction with colleagues in Europe will be required. Some ability for taking calls outside of normal hours (9-5 M-F ET) will be necessary. 

For example, they may have calls from 7 am some mornings and then chat with manager in the evening, but this will vary greatly on the day-to-day business needs and may be dependent on whether it is summer or winter. 

If local to , then there may be the opportunity to spend time in-person with another team member while on assignment. Other members of the team are located in Australia, Germany, and North Carolina. Candidates don't have to be local to the office, but Eastern time zone is preferred.

Minimum Requirements:

•      Bachelor’s degree in a scientific/medical/pharmaceutical discipline (other commensurate qualifications and/or related experience in industry considered if equivalent)

•      At least 3 years working in a Clinical Development and/or regulatory affairs environment

•      Sound understanding of the drug development process

•      Working experience with global clinical transparency regulations, eg EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation 536/2014

•      Knowledge of ICH GCP

•      Awareness of the Clinical Trial Application process and/or the contents of the clinical modules of the Marketing Authorization Application

•      Awareness of privacy regulations, eg GDPR, anonymization concepts and their application to documents (and data sets strongly preferred)

•      Working independently on assignments of moderate complexity and the ability to organize work and handle multiple projects at the same time

•      Demonstrated interpersonal, communication and negotiation skills to effectively work with teams and vendors in a global environment

•      Ability to apply knowledge and experience to solve problems in a pragmatic way

•      Familiarity with MS Office suite

Preferred / Desired Qualifications:

•      Clinical disclosure and transparency experience

•      Familiar with the concept of commercially confidential information generated during the drug development pathway

•      Background as a successful Clinical Trial Associate, Entry Level Scientist, or Reg Affairs Associate and eager to learn

Job Description: Solution Architect - Plasma Center End User Computing

Technical Architect for a collection of Digital Workplace solutions. You work closely with service providers and software-as-a-service vendors to ensure that the design of End User Computing solutions for our Centers is robust, well documented, meets company requirements and minimum security & compliance controls. You will be responsible for the end user computing equipment and services within our Centers global provided via the following technologies:

•      Thin Client technology - IGEL operating system including peripherals.

•      VDI technology-based on Citrix

•      Industrial Mobile Devices managed via SOTI Mobi Control

•      Printer Management (Label printers, Multifunctional printers)

•      Windows 10/11 Tablet and Laptops

You will oversee enhancements to existing solutions through continuous delivery and drive innovation by constantly evaluating emerging technology trends.

Responsibilities:

Technology Development

•      Develops and establishes enterprise-wide technical strategies, designs, and plans that support Business strategies.

•      Define repeatable design patterns for engineers to follow in the implementation of solutions.

•      Supports changes to policy, procedures and standards relating to the enterprise infrastructure landscape.

•      Monitor technology trends and seek ways to enhance continuous improvement initiatives.

•      Research and make recommendations for any technologies or practices that would maximize current investments.

•      Facilitate automation deployments to reduce manual processes and improve efficiencies across systems and data centers.

•      Ensure technologies and processes are simple, standard, and integrated.

Daily Operations

•      Troubleshoot level 3 technical issues of complex scope, specifically recurring problems impacting centers productivity.

•      Provide oversight to managed service provider technical teams, ensuring quality outcomes.

•      Consult with IT teams to help them use our platform and devices on which they run their applications.

Projects and Business Change

•      Build prototypes, proof of concepts, or full product deployments.

•      Work collaboratively with internal employees, vendors, and consultants to ensure solutions are implemented according to design.

•      Support changes to policy, procedures and standards relating to the enterprise infrastructure landscape.

•      Alignment to enterprise-wide systems strategies, standards, and practices relating to the enterprise application landscape.

•      Analyze resource requirements and usage and suggest options to improve and cut costs.

Technical Knowledge

•      Maintain a working knowledge of current technologies and best practices related to the technology area.

Qualifications:

•      Bachelor’s Degree or equivalent experience; educational concentration in a computer-based discipline (e.g. Computer Science, Information Systems) or a technical discipline (e.g. Engineering, Mathematics) is preferred.

•      7+ years of related experience working with integrated enterprise systems is required.

•      Pharmaceutical/Biotech or similarly regulated environment experience is preferred.

•      Expert level experience in translating business requirements into solutions.

•      Expert level experience in working with remote locations.

•      Experienced in working in virtual teams within a matrix organization.

•      Demonstrated abilities in communication, customer service and teamwork.

•      Experience in designing solutions in the areas of end-user computing:

       o      Thin Client technology with IGEL operating system

       o      VDI technology-based on Citrix

       o      Mobile Devices (Honeywell CT60 or similar Industrial Mobile devices)

       o      Label printers

       o      Multifunctional printers

       o      Windows 10/11 Tablet and Laptops

•      Strong technical understanding of: IGEL UMS; SOTI Mobi Control, Intune (optional); Windows client Operating Systems; Printer Management.

Skills

•      Diverse level of knowledge with industry standard server hardware, operating systems, storage area networks, virtualization, and networking technologies.

•      Troubleshooting skills combined with the ability to propose and implement sustainable solutions.

•      Ability to develop business knowledge and acumen.

•      Must be able to make good critical decisions balancing technology, frameworks, strategy, and practical constraints

•      Expert level in areas of end user technology.

Flexible working hours, remote work possible, 1-2 days per week working from the office.

• Generate and develop standard operating procedures and system support.
• Analyze operational process problems and recommend appropriate corrective and preventative actions.
• Manage change control authoring and execution.
• Participate in the site and network wide teams to provide cybersecurity alignment and direction.
• Provide 24x7x365 support of our automation systems and perform automation activities for capital and non-capital projects.
• Modify moderately complex to highly complex control logic that requires a degree of scientific and/or manufacturing process expertise.
• Mentor and guide junior staff and serve as a technical trainer, whenever necessary.
• Clearly communicate progress and issues to peers.

Qualifications

Must-Have

8 years of relevant experience; OR an Associate's degree with 6 years of experience; OR a Bachelor’s degree with at least 3 years of experience; OR a Master’s degree with more than one year of experience

• Experience with writing software test plans, user requirements, and system design documents
• Experience on Automation Compliance projects
• Familiar with process controls equipment
• Strong knowledge of Computerized Systems, Compliance regulations and standards
• good communication skills and training abilities
• Excellent interpersonal effectiveness and communication skills {written and oral}
• Ability to learn new technologies and adapt to change

Nice-to-Have

• Technical troubleshooting experience within tight timelines
• Relevant pharmaceutical experience
• Understanding of programming, and proficiency in at least one language

****3 days onsite, 2 remote****

Construction Project Manager to sit in NY. This individual would be responsible for overseeing the design and construction from start to finish of a new lab building. This role will have some travel internationally that will be expensed (roughly once per quarter) to look at and expand other sites in Europe/ Canada etc. This PM should have experience working as a construction Jr PM or PM working on labs which could be within universities or pharma. This PM should also have some experience working on interior work and have an interest in international projects. This role will be on the owners side so any experience there would be great. They will be responsible for the full project lifecycle- they will manage some design, contractors, stakeholders and will be doing some ordering materials, getting people to install materials, writing and sending out RFPs, profit and loss management, and presenting project progress to executives.

Resume: Wants to see commitment, good standing contract length. Very focused owners rep. Jack of all trades,

Education: Architectural, Engineering, or some form of construction background and/or degree

Day to day: drawing reviews, financial management, reviewing invoices, field visits on construction sites, working with real estate, interfacing with end users. 

Experience: Read drawing, experience on owners side, spent time working in facility in capital projects. Managing projects, Lab experience.

Title: Senior/Principle Scientist/Immunologist

Position details: 

Seeking a Senior/Principle Level Scientist (10+) who has experience with drug development and manufacturing in pharma. The candidate must have experience with dose-response modeling and using dose-specific effects to optimize antibody production. 

The candidate will need to know flow cytometry and have some understanding of statistics for they will developing/validating a quantitative assay to determine biotarget antibody levels in equine serum using a flow cytometry and statistics.

The candidate will work 100% independently. 

Degree: Master, PhD in Biology, Molecular Science, or Immunology. 

Required: GMP and or GLP Experience, Cell based ELISA, Flow Cytometry, Immunology, Bioanalytical Method Development

Plus: R&D Project Management Experience

Title: E&I(Electrical & Instrumentation) Engineers

2 Spots

Location: Alabama

LOA: 2-3 months

Start Date: 6/21 - 6/28/23

Shift: Night Shift

Skills:

E&I Engineer (Electrical & Instrumentation)

Trouble Shooting

Electrical Work

Familiar with controls- PLC Allen Bradley 

Experience in Food and Beverage

Job Description

Essential Duties and Responsibilities:

·      Responsible for the manufacture of consumer foods which comply with all food safety, quality and regulatory requirements.

·      Understands and supports company and site safety policies and performs work related activities in a safe manner. Recognizes unsafe work conditions, coaches peers, and suggests new safety standards as appropriate.

·      Understands, follows, and improves documented operational, maintenance, and sanitation standards in a Good Manufacturing Practices (GMP) work environment.

·      Inspects, maintains, troubleshoots, and repairs electrical, instrumentation, controls, and automation equipment and software.

·      Proficiency in operation and troubleshooting of the following:

o   Power Distribution

o   Studio5000 or Logix5000 platform hardware and software

o   Drives and Motion Control

o   FactoryTalk ME & SE

o   Ethernet/IP Control Network

o   Food Manufacturing and Utility Instrumentation

·      Maintains and properly operates electrical testing equipment.

·      Utilizes drawings, prints, and instruction manuals to determine proper steps to be taken for equipment preventative maintenance, troubleshooting and repairs; adheres to company drawing and documentation standards.

·      Performs preventive maintenance activities and work orders in a timely manner to maximize performance of plant equipment. Improves and modifies preventative maintenance activities as appropriate.

·      Coaches other team members on electrical, instrumentation, and controls skills, machine functionality, defect identification and resolution, and equipment repair.

·      Active participation in training and qualification programs for designated line/area; participate in assessments, ensure effective training, and maintain consistent qualification standards.

·      Uses continuous improvement tools, including breakdown elimination, to eliminate losses and drive issues to root cause; documents, communicates, and implements corrective and preventative actions.

·      Serves as an owner of one or more technical, safety, or quality systems; responsible for building technician skills and providing ongoing coaching.

·      Creates documentation as needed (SOPs, Job Aids, PM Improvements, etc.).

·      Increases skills and knowledge by attending technical training sessions, participating in vendor visits and scheduled maintenance activities; attains expertise in advanced E&I technology (networks, servers, FactoryTalk, motion controls, etc.).

·      Attains and maintains low voltage qualification within six months of start date.

·      Uses a computer to input and maintain accurate records and data; can utilize e-mail and online training resources.

·      Maintains accurate electronic database of repair and maintenance activities, including parts usage and time tracking.

·      Assists in maintaining and developing plant drawings and documentation.

·      Facilitates effective shift pass-downs with the prior/next shift to discuss safety, quality and production issues.

·      Lead projects to improve safety, quality or production results in a designated area.

·      Works as part of a team and assists fellow employees as needed.

·      Other duties as assigned.

Essential Skills and Knowledge

·      High School Diploma or equivalent is required

·      Associates, technical degree or training is preferred

·      Minimum 3 years of relevant experience with electrical systems, PLC, motor and motion controls, SCADA systems, device and information networks, sensors, instrumentation equipment for manufacturing is required

·      Previous mechanical/maintenance experience is preferred

·      Previous food manufacturing experience is preferred

·      Willing to work a flexible schedule as needed

·      Able to read, understand, and follow documents such as safety policies, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and general instructions

·      Working knowledge of general electrical safety

·      Working knowledge of electrical schematics, power distribution and controls, motor and motor controls, PLC logic controls, HMIs, and other industrial controls

·      Able to understand and carry out both oral and written instructions

·      Good communication skills, including the ability to give and receive feedback

·      Able to provide leadership and prioritization in designated equipment area

·      Able to set and meet goals

·      Able to prioritize and manage workload in a changing environment

·      Able to work both independently and on a team

·      Works well with support personnel to maintain high standards for safety, quality, and reliability and drive improvements

·      Able to make data driven decisions and engage others as appropriate

·      Basic mathematical, statistical, and analytical skills

·      Excellent computer skills

·      Able to learn company specific computer systems, including maintenance enterprise system

·      Desire to work in a constantly changing, progressive environment

·      Able to perform the key responsibilities outlined above in accordance with safety standards and practices

·      Physical requirements for the job include the ability to:

o   Lift and carry up to 60 pounds

o   Stand, sit, walk, enter confined spaces, push, pull, kneel, squat, and climb

o   Perform repetitive actions, reach, and feel

o   Hear, speak, and see

o   Climb stairs and ladders

Schedule: Candidates needs to be open to all shifts (day or grave) 6am-6:30pm / 6pm-6:30am.

This position will be onsite.

Technical:

Exhibit detail-oriented documentation skills to ensure Right-First-Time operations.

Escalate process issues as necessary to ensure resolution of issue.

Comply with cGMP, SOP and manufacturing documentation.

Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.

Safe operation of tools and shop equipment, and safe execution of work in the field.

Computer skill level appropriate to navigate and use corporate intranet and related applications, CMMS/CCMS, and standard word processing and spreadsheet programs.

Ability to interact and communicate appropriately with Manufacturing, Quality, Technology, Engineering, and other departments to ensure satisfactory performance of instruments and systems.

Assistance with systems start-up and validation.

Collection and organization of technical data from equipment manufacturers, equipment users, and engineering personnel.

Assistance with identification. Purchase and organization of spare parts.

Installation, calibration of process control instruments or systems, laboratory instruments and analyzers, and support utilities.

Troubleshooting and modification of process control instruments or systems, laboratory instruments and analyzers, and support utilities.

Programming/configuration of microprocessor-based equipment {PLCs, DCS, smart devices, etc.)

Train other technicians in group and individual settings.

Ability to read and understand Piping and Instrumentation Drawings.

Evaluate, review Standard Operating Procedures content and red line where appropriate.

Skills

Knowledge/Skills/Competencies

Has full knowledge of the job and a general knowledge of related functions.

Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex assignments within defined parameters.

Thorough knowledge of the fundamental operating principles of industrial process instrumentation and systems.

Ability to distinguish colors.

Education

High School Diploma

Experience (may vary depending on site size/scope)

5-6 Years related experience

4 years in manufacturing process instrumentation and control and/or analytical instrumentation or a closely related job preferred.M would be preferable.

Experience with SAP and Blue Mountain RA

Description

Candidate must have DeltaV design, configuration, and testing experience. This role will support site projects to implement and test DeltaV software changes for new products and technologies being introduced to the manufacturing process. This position is onsite in Oceanside, CA.

Requirements:

8 years of DeltaV coding experience

Background in biotech / life sciences industry

Be able to report onsite in Oceanside a majority of the time

Duties

Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.

Produce and review design drawings and specification documents (URS, FS, DS, etc.).

Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services.

Generate, execute, and review Installation, Operational, and Performance Qualification protocols.

Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.)

Execute and track progress of change records.

Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.

Troubleshooting of automation and critical process utility systems.

Lead plant operations to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.

Adhere to site SOPs and WIs for daily and project deliverables and provide improvements to business processes.

Attendance and participation in department and staff meetings.

Maintain training qualifications.

Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.

Track project deliverables, and provide status updates to project team.

All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.

Skills

Experience with Biopharmaceutical manufacturing, design or/and construction.

Knowledge of process, utility and building control systems.

Knowledge of GMP guidelines, experience in generation of controlled documents.

Qualification experience related to control and computer systems.

Ability to generate engineering drawings and specifications.

Knowledge of ISA standards and practices for instrumentation.

Knowledge of PID control theories and techniques.

Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred).

Practical knowledge of distributed control systems, and associated programming languages – ***Strong DeltaV Coding***

P2 experience is strongly preferred.

Knowledge of computer aided manufacturing automation.

Demonstrate good organizational and time utilization skills.

Demonstrate good written and verbal communication skills.

Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.

Demonstrate strong working knowledge of PC based programs and web based systems.

Ability to work most of the time independently with minimal direct supervision.

Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.

Education

Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 5 years’ experience, or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 4 years’ experience.

Minimum of 8 years applicable automation and/or instrument and control system experience.

Minimum of 5 years in the pharmaceutical/biotech industry/GMP experience.

The Project Schedule Engineer is a key member of the project team and is responsible to lead and facilitate the project planning and scheduling efforts, monitor and control the performance of the project progresses, and assist the Project Manager to formulate necessary corrective actions.

Duties and Responsibilities

- Adhere to and enforce Roche policies and procedures

- Extensive experience planning and scheduling on complex Good Manufacturing Practice (GMP) biotech projects.

- Facilitates understanding and alignment across multi-disciplinary groups and partners on a complex project.

- Extensive knowledge Commissioning, Qualification, Validation, and Automation are integrated in a GMP Biotech project.

- Ability to prioritize competing demands and manage multiple stakeholder requests.

- Responsible for developing Integrated Project Master Schedule according to Roche standard and Engineering Manual, including establishing schedule contingency and baseline schedule

- Collaborate with project team to establish Project WBS and Work Packages

- Participate in RFP preparation and bid reviews to ensure contractors’ and vendors’ schedule performance capabilities

- Support contractors and vendors in developing discipline schedules to meet Project goals

- Review various discipline schedules for its technical integrity, soundness of the contents and logic, and accuracy of updates

- Facilitate pull planning sessions and support the implementation of Last Planner® System and Lean Construction

- Assist Project’s strategic planning and perform “what-if” analyses as needed

- Apply change management process, evaluate the need for rebaseline and perform it as needed

- Cost- and resource-load schedules as needed and assist resource planning

- Perform or assist Risk Workshops and risk review sessions, and perform Monte Carlo simulations as required, interpret the results for the project team

- Monitor project progresses, update Project Master Schedule and other relevant project schedules, report out and communicate the status

- Analyze schedule performances (use Earned Value method as appropriate) to detect and understand variances from the Baseline, identify early warning of schedule trends, provide schedule forecasting, and assist project team in taking corrective actions

- Perform schedule analysis such as critical path analysis, float trend analysis, variances analysis, multiple float paths analysis, etc. and provide the team with recommendations

- Perform job progress walks periodically and check schedule updates accuracy

- Provide input to the Project Monthly Reports and the Project Data Collection Report

Typical Minimum Requirements

Education / Experience:

- Bachelor or University degree in engineering / economics / business administration

- PMI or ACCEi Project Control Professional qualification or equivalent

- Min 5 years work experience as project schedule engineer

Knowledge / Skills / Competencies:

- Project Management and Project Controls

- Experience in Biotech or Pharmaceutical CAPEX projects is preferred

- Knowledge and experience in the Last Planner® System and Lean Construction is preferred

- Proficiency in Primavera P6, MS Project, Monte Carlo Simulation software such as Pertmaster or Safran Risk, MS Office, Google Suite

- Knowledge and experience in Earned Value Management

- Very good communication and interpersonal skills

- Very good analytical skills

Description:

We seek an outstanding candidate to join the formulation screening efforts in the Synthetic Molecule Analytical Chemistry Development. Responsibilities include designing and performing high-throughput screenings (HTS) for novel dosage forms and drug delivery systems, especially lipid nanoparticles (LNPs). Other responsibilities include solubility determinations, salt/crystal/polymorph characterization, amorphous solid dispersion screening, stability and drug release measurements, LC-MS and other analytical studies supporting early-phase pharmaceutical development. The successful candidate will accomplish our mission through creative problem-solving, use of state-of-the-art lab automation technologies, as well as innovation and collaboration with our subject matter experts.

• BS/MS in a relevant scientific discipline (chemistry, pharmaceutical sciences, or chemical engineering preferred) with 0 - 5 years’ industrial experience in pharmaceutical formulation development.

• Candidates must have solid theoretical knowledge of pharmaceutics, analytical, physical, and/or organic chemistry.

• Experience in formulation development of lipid nanoparticles and other novel drug delivery systems is preferred.

• Hands on experience in analytical instruments including particle sizing, UV/Vis and fluorescence spectroscopy, bioanalyzer and fragment analyzer, UPLC and LC-MS, etc.

• Backgrounds in lab automation, high-content data visualization and mining, and hands-on experience in robotic liquid and solid handlers are plus.

• Capable of designing high-throughput experiments, solving technical problems, analyzing data, and reporting results to teams.

• Candidates should be self-motivated, have good communication skills, and the ability to work in a collaborative team environment.

Our Client is open to fresh BS/MS grads who demonstrate strong motivation and capability in academic lab research, to candidates with junior (? 3 or 5y) experience in industry. Experience in LNP delivery is strongly preferred. No PhD candidates

• GMP / Non-GMP
• Building civil / architectural / site prep (turn-key experience a plus)
• MEP / CSA
• Previous Greenfield experience with Pharma sites
• Experience managing EPCM design deliverables, sign-off and approval
• Avail. ASAP
• Prepare cost and schedule estimates for funding request

Start/End Dates: 9/25/2023 - 9/24/2024

 Worker Location: - NC - Holly Springs

 Job Title: Quality - Quality Assurance Associate

 Job Description: Job Title: Quality Assurance Associate (QA-Engineering)

Length of Assignment: 12 months

Shift/Schedule Details: standard business hours (8-5 pm / Monday-Friday)

*Following an initial 6-week training period, this role may allow up to 2 days per week of remote work, if approved by the hiring manager*

Location: Onsite required Tuesday / Thursday plus a flex day with manager approval following training

Job Description:

The contractor will be a member of the QA-Engineering team at the Holly Springs Vaccine manufacturing facility, supporting QC/Bulk and/or Fill-Finish Operations. The QA-Engineering contractor applies quality principles related to equipment qualification, method validation, process validation, Cleaning validation, shipping validation, and technology transfers. Utilizes integrated commissioning and qualification principles to ensure compliance with equipment and system qualification. Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance-related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.

-Ensures that qualification, validation, technical protocols, and reports comply with site SOPs. Provides review and approval of related documents.

-Provides QA oversight to equipment qualification, method, cleaning, and computer system validation including revalidation and re-evaluation. 

-Provides validation documentation lifecycle oversight.

-Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance-related matters are provided to the site. -In addition, ensures Good Engineering Practices are followed according to GAMP, ISPE, and Company standards.

Minimum Required Qualifications:

Bachelor's degree in Science or Engineering

5+ years of related experience in Quality Assurance and/or in a GMP-regulated environment within the pharmaceutical industry or equivalent

Must possess experience and a solid understanding of method transfer and validation, equipment qualification, cleaning validation, and/or process validation

Must be a collaborative worker, developing relationships with key individuals in the work teams, offering assistance, and sharing resources with other team members

Preferred / Nice to Have Qualifications:

Experience in: Manufacturing, Quality Assurance, E-compliance, Method Validation

Experience in international regulatory and legislative requirements is preferred

Reason for request: sa-mRNA project support

Process/Production Engineer/Technical Resource

Resources to support the Modernization facility startup efforts. Technical resource to serve as a Process/Production Engineer in support of the facility : Media Fills, Stability batches, water runs, PV batches, general production startup. Individual should have a clear understanding of Data Integrity and Change Control requirements and a clear understanding of how to interface with and navigate equipment HMI’s, to operate, troubleshoot and improve system operation. Person will be part of a focused/autonomous team to expedite startup activities and ensure success of a manufacturing area/line/process. NLT 3 years of pharma sterile injectables experience expected.

Resource will report into the Lead Process Eng and/or Process Eng manager at the site and will work directly with cross functional teams (automation, Ops, quality, maint, reliability, Instrumentation, Validation and MSAT), within the operations space to support technical issues, provide engineering assessments of events for process/product impact, identify and facilitate process improvements and robustness, perform data analysis for RC determination and process optimization, lead troubleshooting efforts, own and support change control, and work side by side with operations daily in support of optimization efforts for preparing the site for BAU (business as usual). BAU support will include document reviews/edits to enhance process/machine specifications, procedures, job aides, training, and improved methods of work to streamline the processes. Provide coaching and knowledge transfer to operations and maintenance personnel. Person is expected to have a strong technical understanding of relevant processes and able to understand established system matrixes for products and commodities, able to perform protocol development for engineering studies, execution of testing to define process parameters/ capability to include recipe development and parameter identification. All work to be performed according to site procedures using cGMP and good documentation practices and performed against site commitments/needs. Work will include 12 hour shift coverage working a 3-2-3 work schedule in support of multiple shifts of operations. Resource is expected to have a solid understanding of mechanical systems, system controls and instrumentation. Persons will be expected to help build knowledge management systems/engineering playbooks as well as use of OsiPi to build dashboards for their respective areas of support.

Personnel are expected to work 100% onsite and within the operations area (clean room areas, gowning required). Personnel may require Aseptic training/certification for the job role, so person must be able to work within cleanrooms for extended periods daily. Persons with technical knowledge and understanding of the following processes/technologies/applications are preferred:

• TPO filling
• Commodity Washers
• Depyrogentation tunnels
• Cappers
• CIP/SIP processes
• Formulation tanks/transfer systems
• ATEC stopper processing
• Partswashers
• Autoclaves
• VHP processes (chambers/Isolators)
• OsiPi
• Batch Engines
• SCADA systems
• Production/GMP Documentation – protocol generation, SOPs, Batch Records, Training aides, GMP regulations, PDOCS, EQMS/QTS, EAMS

Location: Remote

Client Industry: Biotech

Job Title: GLP Auditor

Job Duties: Gap Analysis; followed by SOP review, Interviews of SMEs, and summary report generation. The candidate should work in a manner suited for teamwork as the inspection is to help the client build a compliant system. Averaging roughly 20hrs/week, but with 2-3 weeks of 40hrs/week over the course of 2 months. (there may be periods of less than 10hours pending activities).

Degree: 4 year degree necessary or significant related experience

Plus: exFDA experience

10 yrs experience.

They are looking for someone to come in and Write and localize the PQ's for cqv. Help estimate the cost and effort. Write a master plan for PQ scopes, Establish the program and manage the program, make sure the right people are in the correct areas.

Must have experience with Bioreactors, autoclaves, Water systems, gases, steam.

Develops and evaluates quality and system standards to ensure reliability and compliance with company standards and governmental regulatory requirements. Investigates/troubleshoots validation problems for systems and/or performance processes; conducts statistical analyses of testing results and process anomalies; writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes. Ensures that corrective measures meet acceptable reliability standards. Verifies calibration, maintenance and repair of the instruments. May assist with establishing corporate validation policies.

Learning Management System Administrator. Configuring alternate job codes for training assignments. Modify alternate manager roles for performance assessment approvals. Monitor and track training progress for all members of the Innova Program. Compile reports for Training Sites and Deployment Teams. Unlock assessments and complete QA Reviews. Coordinates with the Innova Program and TL&D to support Innova Program initiatives and learning plans. Maintain accurate records and provide support basic technical support. And any additional duties assigned to support the program.

This role will be responsible for contributing to organization design project implementation for a period of 6 months. Effectively communicating with stakeholders, including HR team members, legal, senior business leaders, and employees involved. Will leverage internal and external technology and data to manage and report on timelines and budget adherence, ensuring that resources are used effectively, and to drive decisions. Will contribute to Communications and Change plans that best align with strategic intent, and manage employee employee relations to ensure compliance with policies and practices. Develops and implements procedures to ensure effective implementation. Researches and responds to employee questions, feedback and concerns. Identifies potential risks and develops mitigation strategies to address them. Contributes to effective project documentation and records for future reference. Comfortable operating at a high level, managing sensitive information,

Client is looking for Lab GxP CSV resource to help with software and application upgrades needed at the site (list below). Lots of different facets for this upgrade so would like someone who has done similar upgrades before, but not required. Upgrades are related to software and softmax pro, unicorn, and vicell software; 8 separate applications (listed below) that need to be upgraded, however, if candidate comes with strong CSV for QC Systems they will be fine in the role.

Consultants must come with strong analytical / QC system validation experience. They use the V Model at the site so experience there is good in addition to having strong understanding of 21 CFR part 11 and GAMP experience.

Below are the list of software we need support with. Having experience with these systems or similar would be ideal, however, is not required.

1. SoftMax software – Candidate coming with Softmax SW experience is ideal.

2. WinkQCL software

3. ViCell software

4. Unicorn software

5. CFR software

6. IPU software

7. AccuSEQ software

8. Methodical Mind software

Also, we need support with upgrading the operating systems from Win XP or 7 to Win 10.

Skills:

Lab, GxP, CSV, Validation, Execution, Upgrade

Primary responsibilities for this position include performing tasks associated with USP/EP Compendia for GMP release of raw materials and drug product. The analyst will be responsible for ensuring that samples are tested according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.

Analyst will be required to write change controls, raw material specifications, and perform minor project management work to maintain specifications.

Major Accountabilities:

•          Performs USP/EP testing for QC samples

•          Performs GMP testing and associated tasks without errors per applicable SOPs and protocols

•          Writes change controls, raw material specifications, and project manages changes related to raw material enrollment

•          Coordinates material shipments to third-party vendors

•          Serve as a liaison within multifunctional departments for testing requests. 

•          Assist in laboratory and instrumentation onboarding

•          Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written

•          Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs

•          Participates and performs in cross-training to support staff availability within QC department

•          Develop expertise in assigned assays/techniques

•          May be required to perform shift work to support operational needs

Minimum Required Qualifications:

•          Bachelor’s degree in a Scientific discipline 

•          Some experience with GMPs, safety regulations, and data integrity

•          Some experience with analytical methods and related instrumentation

Preferred / Nice to Have Qualifications:

•          2 years of industry experience is a plus

•          Knowledge of DLS (Dynamic Light Scattering) testing

•          GLIMS LabWare and Empower experience

•          Knowledge of Flow Cytometer

•          Quantitative and Qualitative PCR experience

•          Trackwise and SAP experience

•          Adherent Cell Culture experience

•          Molecular and cell-based assay experience

•          Technical writing skills

Robotics Engineer for the below project(can be a controls engineer with Robotics Experience or just a Robotics Engineer):

As a Controls Engineer II-Contractor, you will work with some of the most talented engineers in the automation industry. This role will enable you to perfect your controls experience while integrating some of the most state of the art robotics & technology available. The innovative solutions we design offer diverse experiences that will strengthen your skills and challenge your abilities.

What You'll Do:

• Design, implement and document controls systems for various types of automated equipment
• Troubleshoot robot controllers, ladder logic, electrical control devices, mechanical units, transfer devices and peripheral equipment
• Perform machine power up, debug and programming
• Ensure equipment is designed and programmed to specifications using standard techniques and approach.

Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.

What You'll Bring:

• Bachelor's degree in Electrical Engineering or related field OR Associates degree with 2+ years of related experience
• 2+ years of related experience

Skills You'll Have:

• Experience with any of the following: PLC's, HMI's, Robotics, Mechatronics, Motion Control, Vision Systems and/or Programming
• Experience with CAD (i.e. AutoCAD Electrical or Solidworks).
• Ability to understand electrical/pneumatic schematic drawings

Other Details:

• Travel up to 25% to customer sites
• Train and mentor 1-2 team members as directed
• Covid-19 Disclaimer: The health & safety of everyone is critical to our success. As an essential employee, you will work onsite at one of our facilities and follow the policies & practices in the Covid-19 Safe Work Playbook. Social distancing, mask-wearing, and capacity limits are a few of the strategies we utilize.

Building Business Process(Typically a PM)

Put together a business process for electronic batch records and documentation 

Electronic batch record qualification and methodology 

How they function

Validation methodology 

Automation Engineer- 10 yrs plus

Rockwell- factory talk, historian

Heavy GMP Pharmaceutical background

Support validation team and vendors bringing equipment on board and helping with start up runs.

New construction site

Please have experience with the following

FactoryTalk Historian

FactoryTalk AssetCentre

FactoryTalk Directory

Studio 5000

GMP/Pharma

Win911

Validation of Computerized systems

MES

design electronic batch records

PAS X software

WERUM

Design for validation

  protocols

  Execute IQ PQ

Compliance Batch Record Documentation

Promote Success of R&D Lab and Office projects through Engineering design, review, Submittal reviews trend data analysis and support commissioning process

Client upgraded from Rockwell MES 7.3 to 9.0 and need additional resources to assist with authoring workflows, recipes, support the process mapping and also conduct testing. This will not require any building from scratch but more taking their past recipes and upgrading them to the new system. This resource will be expected to be able to review, author, and execute these recipes.

Key Skills:

Rockwell MES – MUST

Recipe Authoring

Pharma Experience

• Extensive knowledge of ISPE GAMP5 and ASTM guidelines and proven experience with large and complex projects
• Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation 
• The QA Validation lead engineer will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions associated with site validation activities
• Provide Quality review on the Validation and Maintenance documents of computerized systems 
• Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc. for buildout of new facility)
• Participate in the Validation and Equipment Qualification program at client site and act as QA SME for review and approval on validation documents 
• Provide consistency in the validation approach for equipment, systems, computers, methods, and processes
• Review URS for new equipment, SOPs for equipment maintenance, cleaning, and calibration for each piece of equipment
• Perform change control assessments for existing QC and CMC-GMP equipment to ensure compliance with regulatory requirements in a phase appropriate manner 
• Provide validation guidance/training to QA GMP Staff support cross-functional validation efforts and work closely with Global QA Function (CQA/QMS) 
• Author, review and approve change control & Validation procedures for CMC and Facilities 
• Perform and/or support validation activities, and trend, analyze, and interpret data to monitor performance and support revalidation decisions for changes
• Perform deviation investigations and resolutions through the CAPA system

Competencies

•  Understand emerging technologies (Cell and Gene Therapy)
• Analytical and problem- solving skills, Attention to details and high level of accuracy 
• Strong communication, technical writing, organizational and interpersonal skills 
•  Provide coaching to peers when questions arise and foster teamwork 
• Be reliable and take the lead on projects 
• Thorough knowledge of equipment lifecycle management, calibration, maintenance, cleaning and validation (IQOQPQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities.
• Expertise and working knowledge of cGMP guidelines and knowledge of Quality Systems that meets global regulatory expectations, including knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11 and GAMP 5 requirements, among others

Work environment:

•  Office, Labs, and Cleanroom Environments

• Accountable for the scope/schedule/budget of assigned equipment packages from RFQ through Commissioning & startup
  • Examples: Stainless Steel tanks, Single Use Mixers and Bioreactors, WFI Distribution, CIP Skids
• Representing company in the partnership with an EPCM for a Greenfield facility
• Independently drive equipment packages forward by collaborating with the following departments/personnel:
  • Equipment vendors, EPCM partner, construction contractors, project managers, site Engineering, Operations, MSAT, validation, quality, maintenance.
  • GMP & Sanitary equipment background preferred
• Developing technical packages for equipment
  • Process equipment (custom and off the shelf)
  • Architectural
  • Mechanical
  • Clean Utilities & HVAC as they relate to process equipment and clean room design

• Drawing review & ownership - P&IDs, Layouts, vessels, general arrangements, liaison between EPCM and companyCAD ensuring accuracy of drawings, providing reviews and revisions where necessary, ensuring drawing standards are followed during turnover from EPCM to CAD.
• Review & approval of submittals for components & design documents for alignment with specifications. Support of component, line, and instruments lists for assigned packages.
• Execution and management of wet testing, commissioning, installation of piping in clean room environments
• Plan and execute day-to-day project items to ensure scope/schedule/budget adherence (i.e. crane work, equipment delivery, etc.)
• Support daily contractor permitting as needed
  • Safe work permit
  • LOTO
  • Quality tag out
• Accountable for resolution of issues associated with scope/schedule/budget of assigned packages. 
• Communicate daily issues/problems, escalate as needed. 

• Accountable for the scope/schedule/budget of assigned equipment packages from RFQ through Commissioning & startup
  • Examples: Stainless Steel tanks & sanitary piping systems, WFI Distribution, CIP Skids
• Representing Company in the partnership with an EPCM for a Greenfield facility
• Independently drive equipment packages forward by collaborating with the following departments/personnel:
  • Equipment vendors, EPCM partner, construction contractors, project managers, site Engineering, Operations, MSAT, validation, quality, maintenance.
  • GMP & Sanitary equipment background preferred
• Developing technical packages for equipment procurement
  • High Purity Systems including Clean Steam, Clean Air, Process Gases
  • Water Systems: WFI, RODI, Process Chilled, Heating Hot Water
  • HVAC - Design review through installation, balancing and qualification
  • Cold Room / Refrigeration
  • Black Utilities
  • eGen
• Drawing review & ownership - P&IDs, Layouts, vessels, general arrangements
• Review & approval of submittals for components & design documents for alignment with company specifications. Support of component, line, and instruments lists for assigned packages.
• Execution and management of wet testing, commissioning, installation of piping in clean room environments
• Plan and execute day-to-day project items to ensure scope/schedule/budget adherence (i.e. crane work, equipment delivery, etc.)
• Support daily contractor permitting as needed (in conjunction with construction teams)
  • Safe work permit
  • LOTO
  • Quality tag out
• Accountable for resolution of issues associated with scope/schedule/budget of assigned packages. 
• Communicate daily issues/problems, escalate as needed. 

Location: California

Duration: 1 year

Start Date: 7/28/23

Device Engineer III will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at the client

The candidate has technical expertise in the development and commercialization of drug device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within our clients device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges. The Senior Device Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems.

The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members.

The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines.

Job Responsibilities

The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:

Device Engineering:

• Develop and commercialize devices including interfaces with the primary container.

• Provide guidance and input regarding product development using structured product development process.

• Regularly interface with staff and leaders in Contract Manufacturing,

Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.

• Regularly interact with external development partners and components suppliers.

• Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.

• Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in, and applying training materials for test methods.

Design Control:

• Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.

• Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.

• Participate in hazards analyses and design assessments and reviews.

• Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.

Qualifications

Education and Industry Experience:

• B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.

• At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.

• Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on DOE, problem solving and modelling using physical rules.

Technical Knowledge:

Strong skills in relevant modeling, design controls and/or statistical analysis.

For example:

• Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.

• Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.

• Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, Design for Manufacturability, Molding.

• Full data and statistical analysis (JMP, Minitab) and Design of Experiments.

• Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.

• Six Sigma (Green/Black Belt): DMAIC and DFSS.

• Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses.

Interpersonal Skills:

• Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.

• Excellent communication skills are required. Experience in working with external partners is also highly desirable.

• Highly organized and detail oriented.

• Excellent leadership skills.

Essential Functions:

• Support automation team in daily activities and non-routines tasks.
• Provide support on a daily basis on building management systems, data historian and process control systems.
• Repair, install and troubleshoot automation infrastructure, instrumentation, valve, devices and equipment.
• Support validation activities related to automation systems and equipment.
• Coordinate and provide trainings on automation systems on routine basis.
• Maintain backups of automation codes and backup systems.
• Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes.
• Responsible for ensuring compliance with cGMP practices utilized in bulk drug filling, gene therapy and vaccine/viral manufacturing environment.
• Performs other duties as assigned.

Required Skills & Abilities:

• Knowledge in process control systems, data historian and building management systems, such as DeltaV, PI Historian and Siemens Apogee.
• Computer knowledge of 21 CFR Part 11.
• Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC and Modbus TCP/IP.
• Knowledge with programmable logic controllers, configuration, troubleshooting and operation.
• Support departmental documentation generation and maintenance.
• Capable to use, read and understand blue prints, drawings and complex operational documentation.
• Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles.
• Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities, while maintaining flexibility to do what is needed to accomplish multiple tasks in a timely manner.
• Strong written, verbal and interpersonal communications skills and a strong attention to detail. Must be able to develop, draft and correct preventative maintenance procedures for technical equipment.
• Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, changing work environment.
• Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point).
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.

Minimum Qualifications:

• Associates Degree preferably in Chemical, Electrical, Mechanical Engineering or closely related field with three (3) years of relevant automation engineering experience.

Preferred Qualifications:

• Experience with critical and non-critical utilities, biotechnology equipment and complex pharmaceutical systems are a plus.
• Biotechnology /pharmaceutical industry experience.

Location: North Carolina (with travel to Germany)

Duration: 6-12 months +

Start Date: 6/12/23

Our Client is looking for 3 consultants to provide on-site support for Factory Acceptance Testing (FAT), Commissioning, Qualification and Verification (CQV) activities for the 2 Buildings Gene Therapy Bausch & Stroebel (B&S) Filler installation project between June 2023 and August 2024.  The CQV work will be performed at the facility .  The effort will be governed by established site procedures and processes (i.e., SOP-31414, SOP-31500, etc.).  Cloud Staffing will demonstrate expertise in regulated industry CQV per industry standards and will be able to provide a minimum of three (3) resources, with a minimum of two (2) of those resources having previous experience working with GMP fillers and isolator systems.   

SCOPE OF WORK 

The scope of the Gene Therapy B&S Filler Installation project includes modifications and additions to the 2 Buildings facilities and existing equipment, along with installation of new equipment to support use of Valor vials in the filling process. Verification activities will be required for the following modifications and additions which are within the scope of the project: 

• Installation of two (2) new VarioSys fillers,
• Installation of two (2) new Motus vial outfeed accumulation units, .  The Motus vial outfeed accumulation units will be directly welded into the right airlock of each drug product isolator. 
• Creation of a new sterile autoclave load for the autoclave to accommodate sterilization of new VarioSys filler change parts. 
• Creation of a new parts washer load for parts washer to accommodate cleaning of VarioSys filler change parts.  Only spray coverage testing will be performed during CQV of the equipment. 
• Modification of SKAN isolators and AT filler L-Flanges to include new return air ducts at back of the main chamber and physical modifications to the right airlock to allow for Motus install.  New VHP decontamination cycles will be developed and tested for the B&S L-Flange.  New VHP decontamination cycles will be developed for the AT L-Flange and airlock modifications if existing cycle parameters are not sufficient. 
• Modification of SKAN isolator to replace the existing Windows 8 PC with a new Windows 10 PC.  The existing Human Machine Interface (HMI) will be replaced with a larger model. 
• Modification of Rooms to accommodate filling processes using VarioSys filler and provide more space for operations. 
• Modification of Container Closure Integrity Testers test chambers and change parts to allow for testing of 2R, 6R, 10R, and 20R filled vials. 
• Installation of three (3) new Residual Seal Force (RSF) testers to be used as in-process controls. 
• Modifications to Train 4 DeltaV A314746 (Historian only), DeltaV DCS A388254 (Historian only), and Train 4 PI Historian A388571 to include select monitoring points for the SKAN isolators, B&S VarioSys fillers, and Motus units.   
• Integration of B&S VarioSys control system into the site ALAN for the purpose of domain user authentication and automatic retrieval of VarioSys batch reports from the site Infobatch system. 

CQV DELIVERABLES  

The following CQV services are requested for verification activities associated with the new equipment installation and existing equipment and Distributed Control System modifications and will be performed by the CQV contractors: 

• Participate in all Design Review / Design Qualification meetings associated with the verification deliverables. 
• Aid in generating supplemental FAT addendum test documents, as needed, to test additional site requirements while at FAT. 
• Attend Factory Acceptance Testing and support execution/completion of the FAT protocol. 
• Draft, route, and approve all required verification and performance qualification protocols, deviations, and final reports associated with verification activities. 
• Perform Installation and Operational Verification Testing for two (2) new B&S fillers. 
• Perform Performance Qualification activities for two (2) new B&S fillers. 
• Perform Installation and Operational Verification following Windows 10 installation on B101 Isolator. 
• Perform Automation Installation and Operational Verification testing for new B&S fillers. 
• Perform integrated Installation and Operational testing for two (2) new Motus vial accumulation units. 
• Perform Installation and Operational Verification testing Distributed Control Systems for new or modified points for new or modified equipment. 
• Perform Cycle Development (if needed) and Performance Qualification for a new sterile autoclave load for B&S filler parts. 
• Perform Operational Verification testing (spray coverage testing) for new parts washer load for B&S filler parts. 
• Provide on-site support during vendor-performed isolator Installation and Operational Verification testing. 
• Provide and execute cover protocols for vendor-performed isolator Installation and Operational Verification testing. 
• Provide on-site support during vendor-performed isolator Cycle Development and Performance Qualification testing. 
• Provide and execute cover protocols for vendor-performed isolator Cycle Development testing and Performance Qualification testing.  If needed, perform additional Cycle Development and Performance Qualification testing needed to meet site procedural requirements. 
• Provide on-site support during vendor Installation and Operational Verification of RSF testers.   
• Perform Installation and Operational Verification activities associated with two (2) Container Closure Integrity Testers. 
• Perform Method Qualification following recipe development for two (2) Container Closure Integrity Testers. 
• Provide and execute cover protocol(s) for RSF vendor Installation and Operational Verification testing. 

Review and approval of CQV contractor-generated documents, as well as authoring of the Project Verification Plan, updates to the System Classification Matrices, and authoring of the System Risk Assessments will be performed by the company Verification Project Lead. 

DOCUMENTATION REQUIREMENTS 

• Provide all required project verification documents in the format required per site procedures. 
• Use Good Documentation Practices when writing and executing all required documents. 
• Provide and maintain a project staffing plan. 
• Provide a monthly financial report including spending, cash flow projections, and change orders. 
• 
  
•  

Weekly meetings will be held by the CQV contractor to ensure timely review and completion of deliverables.  The CQV contractor will write and publish minutes from the weekly meetings.  CQV support services will be on-boarded prior to needed verification execution dates to ensure training is completed for necessary documentation and verification activities. 

Day to day:

• Lead PQ conversations for CQV but including all necessary functions such as, but not limited to operations, QA, QC, process support, supply chain, etc
• · Liaise with the operational readiness team to build the connection and define the handover from PQ to operations
• · Build a strategy for how PQ will be executed at the site
• · Work with PQ team at sister site in Europe to clone where possible from SOPs, methods, etc. and develop a plan
• · Define roles and responsibilities during PQ and gain alignment from supporting teams
• · Define key milestones for PQ and develop a timeline for execution
• · Work with project controls to ensure PQ milestones are appropriately reflected in the schedule
• · Develop a communication strategy to ensure the site is informed about PQ and work with the head of CQV to launch
• · Work with project managers to develop tracking tools and visibility to PQ activities
• · Ensure our plan aligns with all necessary regulations and will support successful qualification and future site regulatory inspections
• · Identify all necessary SOPs and need by dates and work with owning functions to ensure delivery
• · Work in partnership with QC teams to determine the appropriate EMPQ/UMPQ strategies
• · Work in partnership with the Supply Chain teams to develop a material resourcing and storage strategy to support PQ activities
• · Develop a strategy for ensuring training of personnel ahead of executing PQ on site
• · Work with the CQV leads, REs, and QA on the implementation of the PQ strategy in their respective areas
• · Develop a high level documentation plan and work with the Kneat leads to ensure templates are ready for execution of these documents

Experience:

• Minimum 15 years Project coordination experience on Large Scale Projects
• · Minimum 15 years PQ experience
• · Experience with liaising with other departments and building PMs/leads, ensuring streamlined FAT deliverables for all buildings.
• Technical knowledge: Technical understanding with an ability to create a vision and communicate it to others effectively
• · Experience with complex projects and working in or around operating facilities.
• · Ability to keep work pace and meet deadlines. Good organizing and planning skills.
• · Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
• · Proven success working well in a team environment with flexibility to react to changing business needs.
• · Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
• · Computer skills (Primavera, Spreadsheets, Word Processing, Visio, Microsoft Project)

Software: Full Microsoft Office Package as above and excellent database Kneat

• In coordination with CQV, process engineering and other project teams, support readiness for coordination of daily, weekly, and monthly activities for your assigned area by gathering data and helping to ensure is it organized and visible.
•  Coordinate and/or facilitate workshops or working sessions as needed to better define project deliverables
•  Help to set up dashboards, metrics boards and other visual tracking tools using software such as tableau, smartsheet, and others
•  Take on projects at the request of, and reporting to, the CQV leadership team.
•  Actively engage with PMs/Coordinators in other teams to ensure alignment and sharing of best practices.
•  Work with project trouble shooting and EHS teams for field coordination activities
•  Adopt the “one team approach” acting as a partner with our EPCM firm to remove hurdles. 

•  Minimum 3 years Project coordination experience on Large Scale Projects
•  Experience with liaising with other departments and building PMs/leads, ensuring streamlined FAT
• deliverables for all buildings.
•  Willingness to take action in a proactive manner for driving progress
•  BA/BS in a related field and project management relevant training or experience
•  Experience with coordinating others, bringing together multi-functional teams in a dynamic yet visible
• way
•  Strong communication skills
•  Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
•  Excellent analytical and problem-solving capabilities
•  Acts with detail-driven ownership and follow through 

Softwares: Full Microsoft Office Package as above and excellent database Tableau

Smartsheet 

Client is looking for an HVAC engineer preferably with a BSME.

3-10 years experience

Look at drawings of duct work and check to see if the HVAC is installed properly per drawings.

Keep running punch list and update

Work with GC so all mechanical systems are commissioned properly

Review drawings in Autocad

Measure for proper sizing

Familiarity with the following:

Air Handlers

Chillers

Boilers

VAV terminal devices

Building controls

Laboratory HVAC construction a plus

As a Controls Engineer II-Contractor, you will work with some of the most talented engineers in the automation industry. This role will enable you to perfect your controls experience while integrating some of the most state of the art robotics & technology available. The innovative solutions we design offer diverse experiences that will strengthen your skills and challenge your abilities.

What You'll Do:

• Design, implement and document controls systems for various types of automated equipment
• Troubleshoot robot controllers, ladder logic, electrical control devices, mechanical units, transfer devices and peripheral equipment
• Perform machine power up, debug and programming
• Ensure equipment is designed and programmed to specifications using standard techniques and approach.

Note: This list of responsibilities is not inclusive; however, it is intended to be a guideline for activities.

What You'll Bring:

• Bachelor's degree in Electrical Engineering or related field OR Associates degree with 2+ years of related experience
• 2+ years of related experience

Skills You'll Have:

• Experience with any of the following: PLC's, HMI's, Robotics, Mechatronics, Motion Control, Vision Systems and/or Programming
• Experience with CAD (i.e. AutoCAD Electrical or Solidworks).
• Ability to understand electrical/pneumatic schematic drawings

Other Details:

• Travel up to 25% to customer sites
• Train and mentor 1-2 team members as directed
• Covid-19 Disclaimer: The health & safety of everyone is critical to our success. As an essential employee, you will work onsite at one of our facilities and follow the policies & practices in the Covid-19 Safe Work Playbook. Social distancing, mask-wearing, and capacity limits are a few of the strategies we utilize.

Leads, develops, and manages process projects. Preparing manufacturing feasibility assessments and capital cost estimates for various process-related projects;  Process support of capital projects, including process design and equipment selection, creation of P&IDs, preparing equipment and construction bid specifications, and acquisition, installation, start-up of process equipment and systems, troubleshooting, and the training of line supervisors, operators and maintenance personnel;  Managing the process engineering portion of capital projects, including cost, schedule, and resources (internal and contractors), as well as leading multi-functional teams in project execution;  Developing processes suitable for implementation in a manufacturing facility within the required project timetable; Process optimization during start-up and early production; and ensuring all process designs deliver personnel safety as well as product safety and quality.

Keys:

-Subject Matter Experience must include expertise in many of the following operations: Powder & Liquid Storage, Weighing and Delivery, Blending Systems, Depositing Systems, Baking and Frying Technology, Seasoning Technology and Process designs for P

Project Engineering Support

Job responsibilities:

• Promote success of R&D lab and office projects at Vertex facilities, through engineering design review, submittal reviews, trend data analysis, and management of the commissioning process (using 3^rd party Cx agents). Scope will include significant new construction and some retrofit projects.
• Facilitate development of energy projects and energy-efficient building design by supporting external and internal engineering studies, investigating energy-saving technologies, developing scope, and working with 3^rd party consultants on designing and implementing improvements.

Required experience and skills:

• Familiarity with laboratory building MEP systems, HVAC controls, and the new construction design process are required.
• Experience in energy-efficient building design will be helpful in this role.
• The role is not expected to involve significant work related to GXP environments.
• Must be highly organized and an excellent communicator who thrives in a fast-paced environment, is adaptive to change, and takes pride in always following through.

The Clinical Trial Supply (CTS) Study Manager is responsible for managing the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Study Manager independently leads clinical studies to ensure compliant, on-time supply of study medication and ancillary materials for our patients. The role includes determining kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing and managing the depot network and distribution to clinical sites, and ensuring final return and destruction. The CTS Study Manager also leads process improvement projects for the clinical supply chain.

Gives input to and oversees the implementation and execution of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies.

Gathers and documents requirements for clinical supplies based on protocol attributes and clinical assumptions.

Leads demand forecasting for study(ies); leverages simulation and optimization tools capabilities to optimize clinical supply plans and minimize the effect of inherent uncertainties; adjusts plans monthly based on actual consumption and changes to clinical and/or supply assumptions; confirms supply plans.

Specifies ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans demand for centrally supplied materials.

Presents IMP related CTS topics in Study Execution Teams.

Determines labelling and clinical kit design based on protocol and countries’ needs; implements pooling concepts in the study.

Establishes and monitors global network of regional and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.

Coordinates timely and compliant importation and resupply of drug supplies and ancillary supplies into regional and global depots. Manages the inventory levels and product expiry.

Ensures on time delivery of drug supplies and ancillary supplies from depots to clinical sites and/or patients.

Develops clinical trial supply documents and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product (IMP) Manuals, product preparation and administration videos).

Trains external stakeholders (i.e,. clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling.

Files proper documentation throughout the study and after study closure.

Utilizes Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites.

Co-develops IRT specifications for drug supply management, participates in user acceptance testing and establishes and monitors inventory levels and IRT resupply settings. Adjusts system settings based on study progress and changes to clinical and/or supply assumptions.

Generates study specific Request for Proposals based on study assumptions, creates Purchase Orders, reviews and approves invoices.

Ensures compliance of all clinical study activities with SOPs and regulations for assigned studies. Participates in GxP audits and regulatory inspections as needed.

Investigates deviations, product technical complaints and temperature excursions (site and transport) in collaboration with CSQ.

Develops global and harmonized SOPs to assure ongoing quality, compliance and efficient conduct of clinical supply activities.

Ensures Plateau SOP training is complete in time.

Creates and updates budgets for complex studies including product and packaging and labeling costs, storage and distribution costs, and comparator and ancillary material costs for assigned clinical studies. Monitors study budget and reports and explains any variances. Processes accruals as needed.

Ensures study reconciliation, returns, and destructions are complete and leads lessons learned sessions.

Identifies opportunities and establishes business cases for process improvement and innovation projects. Independently leads or participates in cross-functional process improvement and innovation projects for the clinical supply chain.

Leads an improvement project team; participates in hiring staff as requested. Mentors junior staff.

Minimum Requirements:

Bachelors Degree in related industry - or relevant work experience (to be approved by hiring manager)

At least 4 years' experience in biopharmaceutical R&D or supply chain

At least 2 years’ experience in clinical trial supplies

Comprehensive understanding of global clinical trial and clinical supply chain processes

Knowledge and experience in GCP/GMP/GDP principles including relevant international standards and regulatory requirements/regulations related to clinical development

Preferred Qualifications:

German language skills a plus

 This individual will perform as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies. This role should demonstrate strong matrix management skills, confidence in working independently, and have proven ability to champion a team to deliver on crucial study milestones. In addition, this individual will be responsible for operating within budget and per established timelines and quality standards.

Must Have Skills

• Demonstrated ability to successfully manage and support clinical trial deliverables from start-up through close-out, including all financial tracking and reporting activities • Understanding of clinical trial design, protocol development, and review • Significant experience with cross-functional leadership and clinical teams, including data review, database lock, and study reporting activities • Vendor management experience is required given many accomplishments will come from external resources • Experience in rare/orphan disease studies is preferred • Experience in maintenance of a submission-ready eTMF required • Experience in Quality Assurance, SOP and study plan writing, CAPA preparation, and closure • Experience with investigator-initiated and industry-sponsored studies • Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations • Knowledge of GDPR and how to apply appropriate practices to clinical trials • Leadership ability and further potential to build relationships in a matrix environment, ability to multi-task in a dynamic and fast-paced environment • Excellent interpersonal, written, and verbal skills required • Working experience/knowledge of timeline management tools (e.g., Smartsheet) • Position title based on experience, capabilities, and demonstrated competencies • Ability to travel in the US and outside of the US as required to visit study sites, vendors, and attend relevant conferences

Start: 3/27/23 - 4/3/23

Duration: 6 Months

Our client is looking for Medical writing for publications. They prefer if someone has experience in rare diseases/genetics/metabolic pediatrics. Client will be looking for someone who can write manuscripts.

Client is looking for a Quality Engineer 7 yrs exp. that can work with out constant direction. Someone that can do the technical validation, who can write the protocols and reports, someone that can establish process's.

Our portfolio has a need to fill a gap for data transfer related to a new property that was recently acquired. We are looking for a temp entry/mid-level person with basic understanding of facilities, work order management, asset/ equipment, PM SOW’s tied to SOP’s. This position would be approximately 4-6 months, work from home, attend meetings as needed and on site/office (Newton/Cambridge/Waltham) visits as required, working exclusively with our Angus work order management system under the direction of management. We would collaborate as needed with guidelines and standards already in place at other properties to bring this particular property work order management system to fully operational in the most efficient manner possible.

• Working with data submitted spread sheets that compliment all relative information related to equipment assets.
  • make, model, serial #, suite locations, floor location, asset tag number.
• Access to Angus system as it becomes live to continue modifying as needed.
• Data input related to useful life of equipment, year installed, details.
• Vendor SOW development tasks.
• Integration of existing SOP/SOW from previous owner.
• PM schedule development from existing, tracking to current and beyond.
• PM work order integration.
• Collaboration with 3^rd party facilities work order management designee to continue development.