Senior Aseptic Fill-Finish Process Engineer

BioSpace; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Flexible PTO

Company-paid holidays

Flexible working hours

Remote work options

Job summary

Syner‑G is seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support a new fill–finish suite buildout within a commercial manufacturing facility.

The role requires hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection, and related equipment, with a solid GMP/regulatory understanding.

Qualifications

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or related field.
• Typically 7+ years of experience in GMP pharmaceutical or biotech manufacturing.
• Sterile, aseptic, biologics, or vaccine fill–finish experience preferred.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

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.

Skills

Aseptic operations

Cleanroom environments

Fill-finish equipment

Documentation skills

Technical writing

Multitasking

Communication

Analytical skills

Problem solving

Independence

Collaboration

Education

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

Job description

Syner‑G is seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support a new fill–finish suite buildout within a commercial manufacturing facility.

The role requires hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection, and related equipment, with a solid GMP/regulatory understanding.