Job Title: Automation Area Lead (x2)

Location: Remote with travel on site to Lebanon, IN periodically.

• This travel will vary for each Area Lead and can come in different variations, for example someone may go on site for 2 weeks, travel home and be off for a week and write code the last week of the month. Or vice versa, this would be up to the consultant to let us know their travel availability.
• Remote work would end in Fall of 2024 and transition to fully on site with expenses paid by client.

Start Date: 4/29 or 5/6

Duration: 12 months with possible extension through 2027

Job description / summary:

• Our client is looking for Two Automation Area Leads to work alongside the Sr. Area Leads and system integrators to write the software, develop the code, do customer reviews, then go into testing when it's delivered to the site and implemented.
• Delta V experience is required as the ideal candidates will need to understand how delta V is put together, they're specifying the control modules, the equipment modules, phases, and specifying how that system will be built and configuring the system.
• Ability to understand how the equipment needs to operate and can write that down in a specification format and then they're responsible for working with other engineers from other engineering companies that actually do the configuration and testing of the software. They won't have a direct role in typing in the code and configuring, they'll be leading the specification and development of the software.
• Have experience writing functional specs and previous experience acting an an area lead/ owners rep.
• Responsible for interpreting the user requirements from the operations teams and process engineering and taking the engineering artifacts and going P&ID, process flow documents, process flow diagrams.
• Software development process knowledge is needed for this role
• Deriving S88 physical model from P&IDs
• Deriving software control strategies from PFDs and related process documents
• Pharma experience with GMP environment experience
• Data Integrity/ Documentation experience
• API/ Drug substance plant- highly automated system.

Lead Area Skills:

Peptides Synthesis

–Continuous and Batch – replicate of existing peptides synthesis plant being constructed in Ireland

–Plug Flow Reactors, Nano-Filtration, Filter Dryer, Packout, CIP

–Will utilize existing code and documentation from Ireland plant as starting point for LP1

Peptides Purification

–Batch – replicate of existing peptides purification plant being constructed in Indianapolis

–Reversed-Phase Chromatography, TFF, Filter Dryer, Packout, CIP

Will utilize existing code and documentation from Indianapolis plant as starting point for LP1.

·        DeltaV Batching. 

·        EM, Phase, Operations, Unit Procedure & Procedures. 

·        Multiple use Equipment. 

·        DeltaV Alarm Rationalization at the EM and Device CM levels.  

·        Facility start-up & configuration. 

·        End to end deployment. 

Must Haves:

• Delta V, Functional Spec writing, software development, S88 Batch Processing, Software Development Life-cycle (SDLC)

Nice to have:

·        GMP Facility experience. 

·        Osi-Pi/ Historian. 

·        Syncade. 

·        Kneat. 

Education/Skills:

• 10-15 years of experience.
• BS Engineering (or equivalent experience)

Location: NC

Duration: 1 year

Start: 4/15

Act as the client's agent to review and approve submittals from the Design/Builder in respect of applicable utilities and equipment designs.  Review and comment on applicable detailed design and installation specifications.  Coordinate equipment design with the assigned automation and controls engineering staff.  Participate in constructability reviews with site construction team.  Support the development of, and review of, tendering packages.  Support coordination of field installations and associated construction schedules and activities.  Assist site construction teams and project controls teams and in respect of the Clean Utilities works ongoing on site.  Assist in ensuring acceptable quality of design and installations.  Drive progress and coordination to ensure schedule, cost and quality targets are met.  Participate in and assist with GMP and quality reviews related to successful GMP installations.  Align with CQV and Construction on System boundaries and have input into review exercise on Clean Utility direct impacting systems.  Provide support on design, operation and review of automation systems, both PLC driven for vendors and Delta-V Emerson for Process Automated Systems based systems. Establish and maintain key stakeholder relationship, understanding their needs and priorities Experience and contacts;  A minimum of 10 years related experience in a pharmaceutical/biotech-manufacturing environment. Knowledge and Skill; We are looking for a candidate with the following background and skill sets:  A bachelor or master’s degree  A proven track record of building strong external and internal relations based on trust  Understanding, experience, and/or formal training working with construction and complex equipment contracts.  Leadership and influence of people not directly reporting to the position.  Ability to keep work pace and meet deadlines. Good organizing and planning skills are a must have.  Demonstrated proficiency communicating and collaborating at a variety of levels with internal colleagues and external construction partners.  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.

This is a 3rd shift spot. They will be carrying a radio, working with 5 pack lines, 1 cook line and 1 evaporator. Looking for someone with Allen Bradly, Ignition, PLC, Scada, some analog and digital experience.

Rockwell FactoryTalk Transaction Manager for SQL Server data storage/acquisition ▪ Rockwell ControlLogix 5000 PLC logic development for machine control ▪ Rockwell RSLogix 500 PLC logic development for machine control ▪ Rockwell FactoryTalk View ME HMI user interfaces ▪ Rockwell FactoryTalk View SE Distributed HMI user interface ▪ AP Thin Manager/Client using FactoryTalk View SE ▪ Rockwell FactoryTalk Asset Centre ▪ Rockwell Factory Talk Batch V11.0

CQV Lead Engineer for all CIP Equipment in the DSM Buildings, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications and Engineering Lists. Lead generation of all CQV CIP Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports. Point CQV person for Vendor review for all CIP Vendor Packages. CQV SME for all CIP Systems. Produce CIP Bridging to include all CCP, CQAs and worst case information of circuits. Lead all circuit reviews for all CIP routes and circuits, working out “worst case” scenarios for testing and cleaning requirements. Liaise with construction manager in relation to construction readiness and a schedule for all CIP systems, perform and lead all field walkdowns for all systems. Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope. Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems. Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all CIP Systems, ensuring all correct predecessors and successors are in place. Ensure Commissioning readiness of all CIP Systems to support Equipment Start-up and IOQ Testing. Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner. Lead CQV CIP Systems with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems. Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all CIP Systems are managed appropriately for the entire Project Lifecycle. Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols Lead execution of all CIP systems and CQV deliverables; FAT/SAT/IOQ Run Weekly CQV CIP Meeting and ensure updates are provided to Weekly CQV Meeting. Role / Title: Roles and Responsibilities for CQV CIP Engineer (Contract role) Reporting to: CIP CQV Lead Start Date: Jun/Jul 2024 CQV

Duration: Dec 2024 Generate and ensure timely approval of all SAT and IOQ Final Reports. Experience and contacts;  Minimum 10 years Equipment experience on Large Scale Biopharmaceutical Projects  SME on all CIP Systems, minimum 5 years  Working knowledge of ASTM E2500 / Leveraging Verification process  Experience with liaising with other departments and building PMs/leads Knowledge and Skill;  Minimum of 10years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.  Minimum 5years experience on Equipment CQV Team  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 (Spreadsheets, Word Processing, Visio, Microsoft Project)  Candidate must be flexible to travel for acceptance tests, OEM site visits, etc. Software; Full Microsoft Office Package as above 

Main Purpose of the Position:

Directly support Tank Management and Warehouse by acting as a key QA contact for issue resolution, discrepancy management, and documentation review.

Solve routine quality issues limited in scope and complexity following all applicable regulations.

Perform assigned tasks and work to achieve company goals and department objectives.

Provide technical review and approve validation deliverables ensuring proper study design and execution.

Maintain the compliance status of the assigned validation areas at a state of inspection readiness.

Working with multiple functions, lead solution of validation issues following cGMP regulations and Genentech standards.

Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design and regulatory requirements.

Provide Quality Assurance oversight to Validation, Revalidation and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.

Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.

Provide technical review and approve validation deliverables ensuring proper study design and execution.

Maintain the compliance status of the assigned validation areas at a state of inspection readiness.

Job Duties/Responsibilities:

Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.

Support the validation program during regulatory agency inspections. Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

Be accountable for behaviors as described in Genentech's Competencies. Provide input into the design and presentation of validation performance metrics. Must be able to work independently, organize and manage projects by demonstrating progress against defined milestones and schedules.

Technical Duties/Responsibilities:

Perform QAR's for cryovessel release(s)

Perform assessor and evaluation activities in DMS

Interact with inter-departmental contacts on discrepancy assessment and resolution

Provide QA oversight to internal and external customers

Provide Quality oversight (including technical requirements and regulatory expectations) of site validation efforts.

Review and approve validation documents (e.g. Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.

Provide technical guidance for study design including sampling plans, acceptance criteria and rationale.

Provide technical and quality validation assessment and approval for engineering and process changes.

Collaborate with departments to ensure validation activities are executed compliantly, with efficiency and effectiveness.

Review, assess and approve Quality Risk management documents.

Participate in the risk stages of procuring new equipment. Collaborate with departments to ensure risk management and validation activities are executed efficiently and effectively.

Review and approve Alarm Review documentation.

Provide input into investigations with potential validation impact.

Provide input and collaborate with other site/functional units and Corporate on validation standards and procedures.

Qualifications / Requirements:

B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency and Genentech requirements.

Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), preferred.

Ability to work collaboratively in cross-functional teams to achieve milestones and goals.

Basic knowledge of EU and US CGMPs and applicable validation guidance.

Ability to make sound decisions about quality and technical subjects.

Ability to communicate clearly and professionally both in writing and verbally.

Description:

Summary:

We are seeking a highly organized and detail-oriented individual to manage complex scheduling, stakeholder engagement, and ensure smooth execution of our governance processes for Translational Medicine. This role is crucial in ensuring efficient operations, effective communication, and adherence to established protocols. You will also be responsible for processing contracts, ensuring accuracy, efficiency, and adherence to company policies.

Responsibilities:

Scheduling & Calendar Management:

Maintain comprehensive calendars for Translational Medicine leadership and key stakeholders.

Schedule governance meetings, considering time zone differences and participant availability.

Utilize scheduling software and tools to optimize efficiency and minimize conflicts.

Proactively identify and resolve scheduling conflicts, proposing alternative solutions.

Manage meeting logistics, including request intake, drafting minute template, and materials distribution.

Stakeholder Engagement:

Identify and track key stakeholders (including, but not limited to key reviewers, team invitees and presenters) across various departments and external organizations.

Proactively manage stakeholder expectations, ensuring timely information dissemination.

Manage communication with internal and external stakeholders regarding meetings, timelines, and governance processes.

Anticipate stakeholder needs and proactively address concerns.

Governance Process Management:

Maintain a deep understanding of governance policies and procedures.

Coordinate governance meetings, ensuring adherence to established protocols.

Prepare and distribute meeting materials and decision summaries.

Track action items from governance meetings and monitor progress towards completion.

Maintain accurate and detailed records of governance activities for future reference.

Contract Management:

Draft, review, and negotiate contracts with clients.

Ensure contracts comply with company policies, legal requirements, and industry standards.

Obtain necessary signatures and approvals from internal and external stakeholders.

Maintain a centralized contract database for easy access and retrieval.

Liaise with various departments (e.g., Legal, Contracts, Translational Medicine) to ensure smooth contract execution.

Respond promptly to inquiries and address any contract-related concerns.

Document Management:

Prepare and finalize contract documents and deliverables.

Standardize contract templates to ensure consistency and efficiency.

Securely store and manage electronic and physical copies of contracts.

Qualifications:

Bachelor's degree in Business Administration, Project Management, or a related field (preferred).

Minimum of 5 years of experience in a related field, such as scheduling, project management, or administrative support.

Proven experience managing and prioritizing multiple tasks simultaneously.

Excellent communication, interpersonal, and organizational skills.

Proficient in Google Suite (e.g. Google Calendar, Sheets) and contract management software (a plus).

Strong analytical and problem-solving skills.

Ability to work independently and as part of a team.

Excellent attention to detail and accuracy.

Understanding of governance principles and best practices (preferred).

Ability to prioritize tasks, manage deadlines, and work independently.

Why is the position open: There is a lot of change @ (the client site); they're transitioning/shutting down the Florida site and sending responsibilities to a new site in California there's responsibilities from a QMS perspective that are changing such as quality plans that need to be managed. 

There needs to be management/follow up on the quality plan(s) and things associated. There are PMs managing things from a task base, but from a compliance aspect they need someone to help maintain, track and work with people to follow procedures and assess situations properly.

The Hiring manager will be maintaining the sustaining related business.

Day to Day: Working with PMs to ensure procedures are followed, tasks are completed per schedule, but also done in the write order, to procedure, to ISO reqs, working with the notified body that audits are set up, notifications of changes are put in, etc. To manage tasks and timelines. Ensuring that the core of the tasks are executed properly.

Software: MS Office systems; not a must- Windchill (PLM), ETQ, Visio for mapping out flows

Additional Information: Everyone in the team and that they work with are engineers.

• Not looking for pharma/biotech people, need to have a solid med device background to keep up with explanation of requirements.
• There is no direct reports to the consultant, it's mostly strategy/execution and potentially additional support for other business needs

Start Date: August

Duration: 2 Years

Location: Hybrid in Atlanta GA, some remote (there are other potential locations a person could work from as well)

Number of positions: Two - 1 SCADA and 1 MQTT/EDGE experience (MQTT would need SCADA exp)

Travel:  For the first 60-90 days, the role will be on site as needed. Could be 25-50% onsite in Atlanta, with potential travel to Greenville SC. Expenses will be covered for travel. Customer has 18 sites total that will need to be upgraded, and the client has offices in areas such as Houston TX, so it is possible that they could have people work from a number different locations if Atlanta is not ideal.

SCADA experience is the key component to this, Wonderware/AVEVA or Oasis7.5 is mandatory

For Both Role:

PLC Programming – Allen Bradley – Process Control – Temp Pressure Levels.

Oasis/AVEVA – SME Scripting

Mid-Stream Oil and Gas related, and it would be a plus to have them.

The client is looking for someone with 8 – 15 year experience.

For the SCADA Role:

The first would be to support a SCADA migration program. They could work remote but would need to be on customer site for a couple days a month.

Develop new and modify existing SCADA applications, programs, and scripts using C, C#, powershell, and VB code in MS Windows and Linux Server environments.

Provide support for SCADA system hardware, software, and field and/or control center personnel.

Support interface configurations between SCADA applications and other real-time, on-line, and batch application processes.

Implement updates to the documentation, design, and administration of the SCADA system and related applications.

Conduct testing and implement changes to SCADA reports, databases, and displays.

Extensive experience w/ AVEVA Enterprise SCADA or (Oasis) 7.5. 

They do not need an expert PLC Script writer, as they have team members for that work. They need someone with extensive experience with Oasis and/or AVEVA (WonderWare).

For the MQTT Role:

The second role would be to support their MQTT program. That would need someone in their office a couple of weeks a month (maybe 2 weeks a month).

Experience with liquids pipeline operations.

Experience with Oracle, PI, LogMate.

Comfortable programming in c# and/or powershell.

Familiar with MQTT protocol and configuration.

Experience setting up new hardware/edge servers and designing the connections back to the central SCADA systems

Location: Ohio

Duration: 1 year

Start: August

Key Responsibilities:

·         Control Systems Design: Develop and implement control strategies for various processes, ensuring optimal performance and compliance with safety standards.

·         PLC Programming: Program and troubleshoot Programmable Logic Controllers (PLCs) to control and monitor equipment.

·         SCADA Systems: Design and maintain Supervisory Control and Data Acquisition (SCADA) systems to monitor and control manufacturing processes.

·         Instrumentation and Calibration: Specify and configure instrumentation devices, ensuring accurate measurements and adherence to industry standards. 

·         DCS System Maintenance: Manage and maintain the Distributed Control System (DCS), including regular inspections, troubleshooting, and software upgrades.

·         DCS Screen Development: Develop, update, and maintain DCS screens to ensure a clear and user-friendly interface for monitoring and controlling the manufacturing process processes.

·         Alarm System Philosophy: Develop and implement an alarm system philosophy, ensuring that alarm systems are designed, configured, and maintained to industry best practices and standards.

·         Key Performance Indicators (KPIs): Establish and steward performance metrics through KPIs related to control system reliability and effectiveness, alarm system effectiveness, and overall operational efficiency.

·         Process Optimization: Collaborate with process engineers to identify opportunities for process optimization and efficiency improvements through control system enhancements.

·         Emergency Response: Develop and maintain emergency shutdown systems to ensure a rapid and controlled response to critical situations.

·         Documentation: Create and update technical documentation, including control system specifications, diagrams, manuals, and records of DCS maintenance, upgrades, and screen developments.

·         Compliance: Ensure that all control systems, alarm systems, and DCS screens adhere to regulatory requirements and industry standards, particularly those related to safety and environmental regulations.

Qualifications:

·         Bachelor's degree in Electrical Engineering, Control Systems Engineering, or a related field.

·         Proven experience in control systems design and implementation within an industrial setting, preferably in the oil and gas industry.

·         Proficiency in PLC programming languages (e.g., ladder logic, function block diagram).

·         Strong knowledge of SCADA systems and HMI (Human-Machine Interface) design.

·         Experience in developing, updating, and maintaining DCS screens.

·         Familiarity with relevant industry standards and regulations.

·         Demonstrated ability to establish and monitor performance through KPIs.

·         Excellent problem-solving and troubleshooting skills.

·         Effective communication and collaboration skills.

Title: Project Engineer/ Facility Engineer

Location:  Grand Rapids, Michigan(on-site)

Project: They're starting a high-speed syringe facility expansion (high speed = ~1000 vials/min)

LOA: 1 Year

Start Date: 7/29/2024 or 8/5/2014

Day 2 Day: Approving documentation; organizing operations through an ETOP(environmental threats & Opps) perspective, work with validation team on CQV from a review standpoint, for example Wfi system(water for injection). 

Additional Info: They don't need to have high speed mfg; They need to know how systems integrate with other equipment, how it's controlled with BAS and how systems work together to bring a system online. They can have experience with Autoclaves or Parts Washers, Wfi etc.

Environment: Aseptic/ Sterile mfg

Education: Bachelors - Technical Degree

Experience Level: under 10 years; preferred 7- 10 years.... will take less experience

Software: (not a must) MasterControl- document system

Duties and Responsibilities:

• Authoring Syncade MES recipes through recipe authoring and resource editor.
• Coordinate the user acceptance testing of MES recipes with peers and internal customers to ensure business requirements are achieved.
• Provide direct internal customer support to manufacturing, site planning, inventory control, quality assurance, quality control, global master data management, and IT.
• Develop and provide operational and technical training.
• Assist in designing, testing, and maintaining the electronic batch record (EBR) MES Recipes and related Enterprise Resource Planning (ERP) system master data, including, but not limited to, items, specifications, lookups, list of values, recipes, routings, and formulas.
• Collaborate among peers and internal customers to determine system business requirements.
• Coordinate, execute, and support User Acceptance Testing of ERP changes and MES Recipe releases with peers and internal customers to ensure business requirements are achieved.
• Maintain the recipe release process to meet manufacturing requirements and to maintain compliant, efficient, and reliable electronic batch records and supporting data.
• Develop and execute change controls and master data change requests for master data and MES Recipe configuration changes.
• Provide direct internal customer ERP and MES support to manufacturing, site planning, materials management, warehouse, quality assurance, quality control, global master data management, and IT.
• Develop and provide technical training for MES and ERP users.

Mandatory Skills:

• Recipe Authoring experience Emerson Syncade (design & development)
• Strong MES (manufacturing execution system) experience.
• WFX 4.6 and 4.9
• Development skills using XML
• Syncade MES

Life science manufacturing business functions like Production tracking, Quality Management, Maintenance, Downtime tracking, etc.

Tech Writer to create, write, document User Manuals. IFU's(instruction for use)

Previous experience writing user manuals

AdHoc 15-40 hours a week AS NEEDED

workload dependent on customer projects

Medical Device background preferred but Pharma is ok

The Construction Manager will have interaction with the client, client relations are a big must. Commissioning will follow after August and this person will be managing Heat Traces and will be doing the permits. Follow on Insulation. The client is behind on the work as a temporary professional left the project last month. 

This person won't be doing any "Lifting" but will be doing the managing. Have basic computer skills, MS Project, Excel etc...

Years of Experience: 10 years

Food and Beverage is a must 

Able to travel to Canada (passport and TN Visa)