Sr. Fill Finish Process Engineer Boston, Massachusetts
Listed on 2026-02-28
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Engineering
Validation Engineer, Quality Engineering, Process Engineer, Manufacturing Engineer
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.
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 a 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.
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.
- 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.
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. Reasonable accommodations may be made to enable individuals with disabilities to…
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