Location: North Carolina

Duration: 1 year

Start: January 2025

Job Description/Skills

• AB/Rockwell PLC
• FactoryTalk View
• Scada
• Automation Engineer will have overall responsibility for managing regulatory aspects of the sites networked engineering data collection, monitoring, and SCADA systems. This individual will provide oversight and compliance during operation and change management of sites Environmental Monitoring System, Utilities Management System, Calibration Management System, and other similar engineering SCADA and Data Collection Systems. The Automation Engineer will provide the necessary leadership, resources (internal and external) to ensure the success of the automation and controls for engineering projects at the site.
• How You Will Achieve It
• Responsibilities include:
  • Assuring various user levels have appropriate, documented training and authorization for access to engineering managed computer systems.
  • Implementation of compliance initiatives including monitoring of system security procedures and practices, review of audit trails and system logins for conformance and assessment of cumulative change impact.
  • Manage and execute automation and controls for capital investments at the site, as well as develop site procedures for documentation of automation control systems, from specifications through operational procedures.
  • Partner with other engineering, production and validation leads to ensure proper project management of all site capital projects.
  • Develop and oversee regulatory design aspects for quality related engineering managed computer systems.

Our client is looking for a hands on Maintenance Technician for a 12 month contract. The contractor has to be very hands on, utility operator, high purity water systems, gas systems, day to day will be to go out and execute validation protocols and they will be walking to equipment with a wrench and fix the equipment. High purity water system experience would be best although they do have gas and steam systems that will be involved along with misc equipment. Consultants need a Pharmaceutical background.

Shift: Primarily Day Shift; potential for Night Shift work in the future

Job Summary:

We are seeking an experienced Cleaning Validation Subject Matter Expert (SME) to lead and execute cleaning validation activities in a dynamic biopharmaceutical environment. This role focuses on Cleaning-In-Place (CIP) processes, cleaning validation execution, and large equipment cleaning strategies, including bio-reactors. The ideal candidate will bring expertise in cleaning validation, MACO (Maximum Allowable Carryover) assessments, and method validation, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities:

• Lead cleaning validation activities, including CIP cycle development, execution, and optimization for large equipment (e.g., bioreactors, tanks, and ancillary systems).
• Conduct cleaning validation studies, execute protocols (IOQ/PQ), and ensure thorough documentation in compliance with regulatory requirements (e.g., FDA, EMA).
• Perform MACO calculations and assessments to determine acceptable residue limits for equipment cleaning.
• Collaborate with cross-functional teams to design and execute cleaning validation strategies and methodologies.
• Develop and execute cleaning validation protocols and reports, ensuring compliance with cGMPs and ALCOA+ principles.
• Provide subject matter expertise in cleaning validation execution and troubleshooting for cleaning processes.
• Lead method validation efforts related to cleaning validation (e.g., swab and rinse sampling).
• Ensure alignment with process and equipment design specifications for cleaning requirements.
• Provide technical training and guidance to operators and validation personnel on cleaning validation principles and techniques.
• Support audits and inspections by providing cleaning validation documentation and expertise.
• May participate in shift work as required to support cleaning validation activities during different phases of production.

Qualifications:

• Bachelor’s degree in a relevant scientific or engineering discipline (e.g., Chemical Engineering, Biotechnology, Chemistry) or equivalent experience.
• 5+ years of experience in cleaning validation, with a strong focus on CIP processes and large equipment.
• Proven expertise in MACO calculations, cleaning validation protocol execution, and method validation techniques.
• Familiarity with biopharmaceutical manufacturing processes and regulatory standards (21 CFR Part 11, ICH Q7, etc.).
• Hands-on experience with large-scale equipment, including bio-reactors, tanks, and associated cleaning systems.
• Strong problem-solving skills and ability to troubleshoot cleaning-related issues effectively.
• Excellent technical writing and documentation skills.
• Flexibility to work day and night shifts as operational needs evolve.

Preferred Qualifications:

• Experience in a large-scale biopharmaceutical manufacturing environment.
• MACO- MUST
• KNEAT experience a plus
• Knowledge of automated cleaning systems and CIP equipment design.
• Familiarity with process validation and cross-contamination control strategies.
• Small Parts COP and CIP execution experience

Process Engineer

Hybrid or Full Time onsite

In this position, you will collaborate with multidisciplinary teams to design, implement, and validate advanced manufacturing solutions, optimizing facility layouts, process flows, and equipment setups. The Process Engineer will lead various project components, from initial scope development to execution and validation, ensuring alignment with our high standards of quality and efficiency.

Key Responsibilities

Technical Leadership and Execution:

• Develop and oversee project design development and execution focused on the manufacture of biopharmaceutical products
• Manage engineering teams during all project phases
• Lead risk assessments, site selections, and capacity planning efforts
• Develop process control strategies and narratives to translate design intent to automation integrators
• Identify and implement process improvements to enhance yield and operational efficiency
• Process data collection and interpretation to support design and process modeling
• Ensure compliance with project specifications, industry standards, and regulatory requirements
• Participate in CQV execution including FAT/SAT, commissioning, and start-up activities
• Develop and execute CQV protocols
• Coordinate with cross-functional teams that include Validation, Manufacturing, Quality, Supply Chain, and Engineering
• Build and maintain strong relationships with internal teams, clients, and external vendors
• Facilitate project meetings, ensuring effective communication and timely execution of tasks
• Create and manage engineering documentation, ensuring quality and compliance
• Enhance decision-making through effective communication, fostering collaboration and consensus
• Advance your technical subject matter expertise within multiple biopharmaceutical technologies and modalities
• Develop capabilities in capital project management, facility builds, validation lifecycles, quality/regulatory compliance, and client management
• Develop baseline knowledge and capabilities in project management
• Engage in ongoing learning within the life sciences to remain at the cutting edge of the industry

Minimum Qualifications

• Bachelor of Science in Engineering
• Minimum of 5 years of experience in the pharmaceutical industry, preferably with a focus on GMP environments
• Understanding of standard process flows in mAb, gene therapy, or cell therapy production
• Subject Matter Expertise in at least one biopharma manufacturing modality
• Demonstrated capability in leading technical project scopes
• In-depth knowledge of engineering principles, GMP requirements, and industry best practices
• Excellent communication skills, both verbal and written
• Proven ability to manage time effectively and prioritize tasks

Beneficial Qualifications

• 8 years of engineering experience within a cGMP-regulated industry
• Familiarity with automation and control systems
• Subject Matter Expertise in at least two biopharma manufacturing modalities
• Experience with design, start-up, shutdowns, return to service, and troubleshooting of manufacturing systems
• Strong project management skills, with prior capital project experience

Targeted start date: 15MAR25. Can start sooner, but there are tangible reasons for this start date.

Duration: ~ 6 Months+

SAP optimization through Equipment and business processes – target areas WH, MFG, QM – Key Objective for this year. Strong skills working with users and building the blue print for the to be solution. Consultant must understand UAT (User Acceptance Testing), Regression testing, and have excellent written and verbal communication skills to interact with users in the warehouse.

WM – experience here is going to be crucial to the optimization project as we believe that better than 70% of the activity will be in the Warehouse. Scanner implementation experience a must. The exact scanner hardware and software has not yet been determined. The consultant will have influence and input on the path chosen. Right now they are demoing a solution to the users with a separate scanner and tablet (tablet mounted to the forklift), but they are not fully opposed to an all-in-one scanner solution. They are using a scanner and tablet set up now, so Validation of a similar solution would be preferable. An all-in-one scanner deployment would trigger a full new validation. Also nice-to-have (almost an absolute must) is someone that understands SAP “Active Ingredients”, which is SAP’s solution for measuring inventory with concentrations (ie a 1 liter vessel with 50% concentration is the same inventory valuation as a 2 liter vessel at 25% concentration even though volumetrically they are different).

Fiori applications – writing new apps/applets mostly for the use of whatever hardware we choose to use. Scanners, IOS??

QM experience – We have a great user base with little experience. Need the savvy consultant to aid in identifying optimization opportunities. Need to have strong candidate to assist with user group Upskilling and potentially provide some advanced training to users or help develop SAP teams ability to do this.

MES/SAP integration – MES Project is kicking off now. We have yet to learn the level of our involvement with.

System Validation – A mature source to provide advice for QVC, IT and SC on how to optimize the various type of changes that are made for the SAP system.

Strong relationship and communication skills desired -

ABAP – Nice to have for writing some new custom coding. Can be achieved other ways.

Related project topics – The next Phases of the implementation will be COI ID (SAP Chain of Identity (COI) ID is a unique identifier that is generated for each patient therapy number in an order), and FICO. They’re full “go-live” date is not until 2027 or 2028

IV CQV Engineer - Pharmaceuticals - North Carolina - 6+ Month Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented IV CQV Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Main Duties

• Reviewing turnover packages from vendors and construction
• Walking systems to ensure installation is correct (knows how to walk and read P&IDs)
• Is able to operate independently after given direction on what to do
• Ensure IV execution is carried out in accordance with engineering specifications, CQV procedures, CQV project strategies, and industry standards such as BPE commissioning and validation guidelines.
• Liaise with Solutions Company and CLIENT in relation to quality of construction documentation intended to leverage for qualification.
• Align with CQV Turnover in relation to review and approval of all Turnover Packages, both VTOPs and CTOPs.
• Liaise with CQV SWAT Team in relation to punchlist closure both pre-MC and during the CQV execution phase for all systems in relation to IV execution.
• Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems requiring IV execution are managed appropriately.
• Liaise with System Owners (Responsible Engineers) for IV tasks, including but not limited to specification deviation requests, PCC impact to test cases, and vendor documentation gaps.
• Coordinate timelines and needs for required IV pre-req documents, including but not limited to VDRs for IV execution, VDRs for OV execution start, QAM reports, CTOP test pack deliverables, and passivation and pressure test documentation from vendors, CMT, and STW activities

They're bringing on a Wfi system, they modified their existing pure water loop over the shuttdown. Current qualifications are being done, loops were decoupled. WFI is being installed 

Write use and operation SOPs from an engineering and end user(point of use) and sampling plans. There may be additional needs pending the persons background.

Plus: Ozonation experience; ambient loop is ideal; SOP templates they've worked with before.

Title: FAT Support/Clean Utilities Consultant

LOA: 6+ months

Location: NC

Scope is Factory Acceptance Testing and start-up support for Clean Utilities equipment including Purified water generation, WFI generation, Clean Steam generation, and pump skids.

• On-site inspection and testing of equipment at vendor sites.
• Review of vendor turnover package documentation.
• Review of vendor submittal documentation.
• Support execution and closure of FAT protocols.
• Support walk downs of equipment after installation.
• Minimal travel required for 1-2 week FATs.
• Preferred: familiar with Kneat Validation Software

SCOPE

This Scope of work is to upgrade Building MCS system, including support for replacement or updates to 30 PLCs, which includes a combination of PLC 5 and ControlLogix.

1. Responsible for training on required site SOPs

2. Support of updates to functional specifications/configuration specifications

3. Support of any change control work

4. Support of protocol/test plan generation

5. Support for execution of electrical/wiring checks

6. Configuration of all I/O for process equipment for replaced PLCs.

7. Support of PLC implementation on development system and live system.

8. Implementation or updates to units, phase logic, control modules, messaging, and any other required functionality in new and existing PLCs, following project standards.

9. Support of PLC integration with new iFIX SCADA system to replace old system

10. Provide commissioning and qualification support, including loop tuning, support of testing, and resolution of deviations and closeout of project documents

11. Support of suite startup/troubleshooting activities for an agreed upon duration after startup.

Phase 1 PLC EF online commissioning and qualification 31MAY25 No

5 QUALITY AND ACCEPTANCE CRITERIA

Indicator/Metric Description of how it will be measured Frequency

PLC EF online

commissioning and

qualification Technical deliverables are completed per validation and project execution plan

Our client is looking for a consultant that has 5-10 years of experience with Construction Management in a Food and Beverage Environment. Additional Process Engineering experience is a plus. While experience in Food and Beverage is preferable they will take experience in Oil/Gas and Pharmaceutical industry experience as well. Ideally someone that can grow with the team and be a long term solution to their construction needs at the Georgia Plant.

Key Responsibilities:

• Project Planning and Execution:
  • Develop and execute project plans, including timelines, budgets, and resource allocation. 
  • Break down large projects into manageable milestones and identify potential risks and dependencies. 
  • Manage project documentation, ensuring accurate and timely record-keeping. 
• Stakeholder Management:
  • Communicate effectively with internal and external stakeholders, including production departments, senior leadership, real estate, and contractors. 
  • Manage relationships with teams, stakeholders, and clients to ensure smooth project execution. 
• Budget and Cost Control:
  • Prepare and manage project budgets, ensuring projects stay within allocated resources. 
  • Negotiate contracts with vendors and manage vendor relationships. 
  • Identify and implement cost-saving initiatives. 
• Safety and Compliance:
  • Ensure that all construction activities adhere to brewery safety programs and industry regulations. 
  • Monitor and supervise contractors to ensure compliance with safety standards. 
• Facilities Management (in some roles):
  • Manage day-to-day operations related to brewery assets, including buildings, infrastructure, and grounds. 
  • Oversee maintenance, repairs, and housekeeping activities. 
  • Manage contracted services, such as janitorial, HVAC, and fire suppression

Other Possible Skills

General Experience / Core Skills:

1) Food and Beverage Industry experience - brewery experience most relevant

2) Sanitary piping design and installation

3) Equipment sizing and performance specification development

4) Strong computer skills –

a. Microsoft project

b. Microsoft Excel

c. Microsoft Outlook

d. Microsoft Visio

e. Auto CADD or Microstation equivalent

5) Good communicator who can effectively describe technical application to all audiences

Core Skills/Job Description:

1) Scope, develop, support bidding, and start up Brewing and Utilities process capital projects

2) Review and provide feedback to order of magnitude estimates from engineering firms, internal providers, etc.

3) Work with engineering team and end users to develop project scope and design

4) Utilize basic project scope to develop design criteria and design basis for projects

5) Develop process engineering details:

a. Pump sizing

b. Line sizing

c. Heat exchanger sizing

d. Tank sizing

e. Specification and selection of valve types and in-line instrumentation

6) Follow AB prescribed engineering process to build engineering deliverables:

a. Develop project scope

b. Develop PFD’s

c. Develop P&ID’s

d. Develop piping drawings

e. Develop drawings lists / tie-in lists

f. Develop construction scope of work

g. Assemble and present complete bid package to internal customers

7) Execute design reviews with team

8) Attend construction bid meetings to support construction team

9) Develop and review Process Description of Operation Documents for programmers to execute

10) Work with programmers to execute changes in the field

11) Be responsible for start-up of project and any onsite or on call requirements

12) Be responsible for punchlist engineering items after start up and close out of project

13) Manage third party engineering firms in execution of capital projects

14) Interface with internal customers on process development and engineering process

1. Requirements:
   1. Minimum of 5 years of experiences in the Medical Device Field.
   2. Experience as a Quality Engineer/Manufacturing Engineer.
   3. Experience in Equipment Qualification including Computer System Validation.
   4. Experience in physical and functional Test Method Validations.
   5. Experience in defining Inspection criteria.
   6. Experience in Product/Process Risk Management.
   7. Experience in Quality Agreement and working with multiple Quality Management Systems
   8. Experience in Electro-Mechanical Capital Equipment
   9. Experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc
   10. Understanding of the regulatory requirements for a commercial release (MDSAP, MDD, MDR, FDA, and ISO standards).
   11. Preferred experience in Product/Process Transfer.
   12. Preferred experience in Agile PLM.
   13. Preferred German fluency.

 Document Control Management: Ο O Ο Ο Manage and oversee the organization of electronic documents, ensuring the proper naming conventions, filing structures, and version control systems are in place. Develop, implement, and maintain document control procedures for both internal teams and external stakeholders. Ensure all documents are readily accessible, with controlled access based on project requirements. Coordinate with various departments and contractors to ensure timely collection, review, and distribution of required documents for turnover packages.

o Perform document audits to ensure compliance with project-specific standards. o Ensure proper version control is maintained for all document packages

이 Collaborate with project teams to resolve any documentation punches, discrepancies, or missing documentation

o Tracking of documentation punches and provide metric reports on punches

Ο Ο Proactively engage with vendors on common documentation punches and common issues to ensure right first-time approach Review and verify that all

documentation requirements (VDR) for handover are complete and accurate

Ensure all documents comply with contractual, legal, and client-specific requirements. o Managing the approval process by sending the document to approved reviewers/ approvers according to an approval matrix. • Following up on documents after an agreed time. • Monitor the status of turnover documentation and provide regular updates, metrics and reports to senior management on the status and any potential delays. 이

Ο Work closely with project managers, engineers, construction teams, and contractors to ensure smooth coordination of document flow and turnover deadlines. Liaise with clients, subcontractors, and third-party vendors to ensure the timely submission and approval of turnover documents. • Address any queries related to document format, structure, or content during project closeout.

o Maintain accurate records of all turnover documentation for future reference or audits.

Ο Utilize document management software for the electronic control and tracking of project documents

Educational Background: A degree/certificate in a relevant field such as Information Management, Library Science, or a related discipline.

Experience in Document Control: Proven experience in managing both physical and electronic project documents, including tracking, receiving, filing, and managing documents. Attention to Detail: Ability to ensure all documents are clearly labeled, indexed, complete, and readable. Technical Skills:

Proficiency in developing and managing an electronic document control plan. Communication Skills: Strong ability to clarify document contents with client and vendor personnel. Analytical and Organizational Skills: Expertise in filing documents in a neat and consistent manner and managing document control storage.

Primary Roles and Responsibilities: Main point of contact for C&Q Program Lead. Create and implement comprehensive C&Q strategies, plans, and schedules to ensure regulatory compliance and meet project timelines. Ensure adherence to C&Q procedures and program strategies in all C&Q activities within the Node. Continuously identify opportunities to improve C&Q practices across the Node, driving efficiency and maintaining compliance. Report directly to the program leadership, providing updates on the progress, risks, and issues related to commissioning and qualification activities

Coordinate FATs with vendors and CMs within their node. Help coordinate the day-to-day C&Q activities within their Node. Review MC acceptance from C&Q Firms. Help coordinate pre-commissioning activities such as Priming utilities Calibration of instruments Automation downloads Installation of consumables (e.g. Filter cartridges) VFD Setup Help coordinate close out of punch list items with C&Q Firms /SWAT Team. 

Liaise with the other C&Q Node Leads Demand on Utilities and temporary power (e.g. steam, water etc.) Coordinate wastewater discharge and load on drains and sumps

Help manage LOTO with the mechanical team. Support/ lead the system handovers to the User team. Report Metrics to C&Q Program Lead Change management (from initial scope) Progress / Metric measurement 2-4 week look ahead Critical path analysis Resourcing Enforce a strong safety culture by ensuring that all commissioning and qualification activities comply with site safety standards and industry best practices, promoting a safe working environment for all team members.