Principal Engineer, Fill/ Finish
Overview
The Principal Engineer, Fill/Finish is responsible for developing and executing engineering strategies that support and expand aseptic drug product manufacturing capabilities. This role serves as the technical expert for fill/finish operations, driving process improvements, validation activities, contamination control strategies, and equipment lifecycle management within a regulated pharmaceutical manufacturing environment.
Key Responsibilities
- Serve as the subject matter expert for aseptic fill/finish operations supporting both drug substance and drug product manufacturing across clinical and commercial applications.
- Lead engineering initiatives focused on process robustness, sterility assurance, contamination control, and manufacturing efficiency.
- Provide technical support during regulatory inspections, customer audits, and compliance activities.
- Drive equipment implementation, optimization, and continuous improvement efforts for fill/finish manufacturing systems.
- Lead investigations, deviations, CAPAs, risk assessments, and root cause analyses related to manufacturing operations.
- Support the full equipment lifecycle, including URS development, FAT/SAT execution, commissioning, and IQ/OQ/PQ validation activities.
- Maintain and enhance sterility assurance programs, including:
- Aseptic Process Simulations (APS)
- Container Closure Integrity Testing (CCIT)
- Environmental Monitoring Performance Qualification (EMPQ)
- Develop and support Process Performance Qualification (PPQ) strategies and validation lifecycle management for filling operations.
- Mentor junior engineers and provide technical leadership across manufacturing and engineering teams.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
- 10+ years of engineering experience within pharmaceutical, biotechnology, CDMO, or drug product manufacturing environments.
- Strong expertise in aseptic processing, fill/finish manufacturing, contamination control, and cGMP requirements.
- Working knowledge of regulatory standards and guidance, including USP and EU regulations related to sterile manufacturing.
- Experience supporting audits, inspections, validation programs, risk assessments, and quality investigations.
- Hands-on experience with fill/finish manufacturing equipment, including:
- Automated and semi-automated filling systems
- Isolators
- Capping equipment
- Inspection systems
- Secondary packaging lines
Travel & Physical Requirements
- Up to 25% travel, primarily domestic with occasional international travel.
- Ability to work in manufacturing environments and around production equipment.
- Must be able to stand, walk, bend, lift up to 50 pounds, and perform activities required in a regulated manufacturing facility.
Short Role Summary
Lead fill/finish engineering activities for sterile pharmaceutical manufacturing, providing technical expertise in aseptic processing, equipment validation, contamination control, and process improvement while supporting regulatory compliance and manufacturing growth initiatives.
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