Sr. Fill Finish Process Engineer
Listed on 2026-04-17
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Engineering
Validation Engineer, Quality Engineering, Process Engineer, Pharma Engineer
Sr. Fill Finish Process Engineer (Future Opportunities)
POSITION OVERVIEW: We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands‑on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations.
This position partners closely with operations, QA, validation, MS&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.
WORK LOCATION: Travel to client sites may be required up to 100% based on project phase and client needs.
KEY RESPONSIBILITIES:
- Support design, construction, installation, and qualification of a new commercial fill–finish suite, including clean rooms, process utilities, and supporting infrastructure.
- Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
- Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
- Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P&IDs, and GMP requirements.
- Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
- Partner with Operations and MS&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA, Validation, and MS&T to maintain validated state of aseptic manufacturing processes.
- Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
- Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
- Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
- Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
- Develop and execute commissioning and qualification protocols.
- Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
- Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines.
- Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
- Participate in project planning, scheduling, risk assessments, and milestone tracking.
- Provide effective communication to stakeholders at all levels.
QUALIFICATIONS AND REQUIREMENTS:
Education
- Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.
Experience
- Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
- Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
- Experience supporting commercial manufacturing operations in a regulated environment.
- Experience with commissioning, qualification, and engineering documentation.
Knowledge, Skills, and Abilities
- Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
- Strong documentation and technical writing skills.
- Ability to manage multiple priorities in a fast‑paced environment.
- Strong communication, analytical, and problem‑solving skills.
- Ability to work independently and collaboratively.
ESSENTIAL FUNCTIONS: Physical Demands - The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job.…
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