Senior Principal Engineer, Sterile Fill
AbbVie
6 months ago
On-site
North Chicago, IL
Operations
Purpose:
The Senior Technical Expert – Aseptic Equipment & Sterile Processing serves as a global subject matter expert responsible for the design, technology selection, commissioning, qualification, and lifecycle support of aseptic manufacturing equipment across pharmaceutical and biologics facilities, ensuring alignment with EU GMP Annex 1, sterility assurance, and contamination control.
Responsibilities:
- Serve as a global subject matter expert for aseptic manufacturing equipment and sterile processing technologies; lead design, specification, and lifecycle management.
- Support global capital projects and manufacturing sites with aseptic processing technical guidance.
- Establish/maintain sterile manufacturing engineering standards and best practices compliant with EU GMP Annex 1.
- Support implementation of Contamination Control Strategies (CCS) and sterility assurance principles (e.g., minimize operator interventions; effective sterilization/decontamination).
- Support contamination risk assessments and provide technical input for regulatory inspections/responses.
- Lead technical evaluations and technology selection (e.g., aseptic filling lines, isolators, lyophilizers, autoclaves/sterilization systems, de-pyrogenation tunnels, CIP/SIP).
- Conduct vendor technical assessments and due diligence.
- Support global equipment standards/technology roadmap and input to capital investment planning.
- Provide technical oversight across design, procurement, and integration; review vendor designs for compliance.
- Lead commissioning, qualification, and startup; review/approve FAT/SAT, commissioning plans, IQ/OQ documentation, and support GMP startup.
- Troubleshoot complex aseptic equipment; lead root cause investigations; support CAPA.
- Provide technical support during critical production/startup events; develop best-practice guidance and standards; train and mentor teams; ensure consistency across projects/sites; foster safety/accountability/collaboration.
Qualifications:
- BS in Engineering (or equivalent); Master’s degree preferred.
- 10+ years as a technical subject matter expert in aseptic and sterile fill operations.
- Proven leadership delivering fill/finish projects from concept to qualification.
- Deep knowledge of engineering systems in a drug product facility.
- Familiarity with fill/finish equipment leaders (e.g., B&S, Syntegon, Groninger, Optima, Skan, EMA).
- Demonstrated experience managing engineering contractors and global equipment vendors.
- Results-oriented leadership with strong negotiation skills and risk-based decision making.
- Ability to mentor and develop next-generation leaders.
- Travel to the US and Europe for design reviews/workshops/vendor visits/installation/C&Q support required.
Benefits (explicitly stated):
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) (eligible employees)
- Eligible for long-term incentive programs
Application instructions:
No application instructions provided in the text.
The Senior Technical Expert – Aseptic Equipment & Sterile Processing serves as a global subject matter expert responsible for the design, technology selection, commissioning, qualification, and lifecycle support of aseptic manufacturing equipment across pharmaceutical and biologics facilities, ensuring alignment with EU GMP Annex 1, sterility assurance, and contamination control.
Responsibilities:
- Serve as a global subject matter expert for aseptic manufacturing equipment and sterile processing technologies; lead design, specification, and lifecycle management.
- Support global capital projects and manufacturing sites with aseptic processing technical guidance.
- Establish/maintain sterile manufacturing engineering standards and best practices compliant with EU GMP Annex 1.
- Support implementation of Contamination Control Strategies (CCS) and sterility assurance principles (e.g., minimize operator interventions; effective sterilization/decontamination).
- Support contamination risk assessments and provide technical input for regulatory inspections/responses.
- Lead technical evaluations and technology selection (e.g., aseptic filling lines, isolators, lyophilizers, autoclaves/sterilization systems, de-pyrogenation tunnels, CIP/SIP).
- Conduct vendor technical assessments and due diligence.
- Support global equipment standards/technology roadmap and input to capital investment planning.
- Provide technical oversight across design, procurement, and integration; review vendor designs for compliance.
- Lead commissioning, qualification, and startup; review/approve FAT/SAT, commissioning plans, IQ/OQ documentation, and support GMP startup.
- Troubleshoot complex aseptic equipment; lead root cause investigations; support CAPA.
- Provide technical support during critical production/startup events; develop best-practice guidance and standards; train and mentor teams; ensure consistency across projects/sites; foster safety/accountability/collaboration.
Qualifications:
- BS in Engineering (or equivalent); Master’s degree preferred.
- 10+ years as a technical subject matter expert in aseptic and sterile fill operations.
- Proven leadership delivering fill/finish projects from concept to qualification.
- Deep knowledge of engineering systems in a drug product facility.
- Familiarity with fill/finish equipment leaders (e.g., B&S, Syntegon, Groninger, Optima, Skan, EMA).
- Demonstrated experience managing engineering contractors and global equipment vendors.
- Results-oriented leadership with strong negotiation skills and risk-based decision making.
- Ability to mentor and develop next-generation leaders.
- Travel to the US and Europe for design reviews/workshops/vendor visits/installation/C&Q support required.
Benefits (explicitly stated):
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) (eligible employees)
- Eligible for long-term incentive programs
Application instructions:
No application instructions provided in the text.