(This list is not exhaustive and may be adjusted as needed.)
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 REQUI
Additional Information
COMPANY DESCRIPTION:
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. To learn more about who we are and what drives us, watch our company video here .
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
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.
For more information, visit www.Synergbiopharma.com
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.
Synerg · Boston, MA