Sr. Fill Finish Process Engineer (Future Opportunities)

About the Company

Syner-G enables people to build careers that positively impact their quality of life. We accelerate breakthrough science and deliver life-enhancing therapies to patients by supporting organizations through drug discovery, approval, and commercialization. Our work is meaningful, varied, and strategically focused, driving real-world outcomes from science to success.

Our culture aligns with our mission, fostering growth, learning, and recognition. Syner-G has been honored with BioSpace's "Best Places to Work" award for three consecutive years, reflecting our commitment to a positive work environment with strong career development, financial rewards, and innovation. Team members are our most valuable asset, and we value their contributions in shaping the future.

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 deep understanding of GMP operations and regulatory expectations.

This role partners closely with operations, QA, validation, MS&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

Work location may require up to 100% travel to client sites based on project phase and client needs.

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 the 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.

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.

Skills

• 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: While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required include close vision and the ability to adjust focus.

Work Environment: The work environment includes moderate noise levels, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office setting.

Benefits

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and culture. This includes:

• A market-competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Generous flexible paid time off program, company-paid holidays, and flexible working hours.
• Fully remote work options for most positions, with the ability to work "almost anywhere." Office locations are available in Greater Boston, San Diego, CA, Boulder, CO, and India.
• Ongoing recognition and career development opportunities.