Sr. Fill Finish Process Engineer (Future Opportunities)

Syner-G•Boston, MA

12d•Remote

About The Position

A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

Requirements

Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.
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.

Nice To Haves

Experience with digital validation platforms such as KNEAT is a plus.

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.