Sr. Fill Finish Process Engineer (Future Opportunities)

Syner-G is a biopharma product development and delivery partner that enhances the quality of life through innovative therapies. They are seeking a Senior Fill-Finish Process Engineer to support the buildout of a new fill-finish suite, requiring expertise in aseptic manufacturing processes and collaboration with various departments to ensure compliance and optimization.

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

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
• Experience with digital validation platforms such as KNEAT