Sr. Fill Finish Process Engineer (Future Opportunities)

About the role

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.

Responsibilities

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, 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.