Remote-Eligible Senior Fill-Finish Process Engineer

Syner-G; Boston (MA); Hybrid; USD 130,000 - 170,000; Full time

Benefits offered by this job

Remote work options

Office locations in Greater Boston

Job summary

Syner-G is seeking a Sr. Fill–Finish Process Engineer to lead the buildout of a new commercial fill–finish suite in our Greater Boston area facility.

The role requires hands-on experience with aseptic formulation, sterile filtration, lyophilization, and related equipment within regulated GMP environments. The ideal candidate has 7+ years in GMP pharma/biotech manufacturing, strong process knowledge, and a proven track record in commissioning, qualification, and documentation.

Qualifications

• Typically 7+ years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong understanding of aseptic operations and fill–finish processes.
• Excellent documentation and technical writing skills.

Responsibilities

• Support design, construction, installation, and qualification of a new fill–finish suite, including cleanrooms and utilities.
• Develop user requirements, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, and related systems.
• Conduct field walkdowns and verify installation details against drawings and GMP requirements.
• Serve as SME for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and inspection.
• Collaborate with Operations and MS&T to troubleshoot technical issues.
• Coordinate with Maintenance to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Maintain validated state of aseptic manufacturing processes with QA and Validation teams.
• Ensure compliance with FDA/EMA/ICH/Annex 1 regulatory guidelines.

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 to lead the buildout of a new commercial fill–finish suite in our Greater Boston area facility.

The role requires hands-on experience with aseptic formulation, sterile filtration, lyophilization, and related equipment within regulated GMP environments. The ideal candidate has 7+ years in GMP pharma/biotech manufacturing, strong process knowledge, and a proven track record in commissioning, qualification, and documentation.