Process Engineer - Tech Transfer & GMP Manufacturing

Syner-G BioPharma Group; Plainville (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Syner-G BioPharma Group in Plainville, MA, is seeking an experienced Process Engineer to lead and support the transfer of manufacturing processes across development, clinical, and commercial sites.

The ideal candidate will have a strong background in process engineering, technology transfer, single-use systems, risk management, and GMP manufacturing, with extensive cross-functional collaboration across site functions and external partners.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or related field and 5+ years in pharma/biotech or medical device manufacturing.
• Experience leading or supporting technology transfer projects within pharma/biotech manufacturing.
• Strong understanding of upstream, downstream, fill-finish, or related manufacturing processes.
• Hands-on experience with single-use systems (SUS) and related deployment.

Responsibilities

• Lead initial technology transfer assessments between development, clinical, and commercial sites.
• Develop and execute technology transfer strategies to support clinical and commercial programs.
• Define CPPs, KPPs, CQAs, and operating ranges; support process characterization and monitoring.
• Coordinate CQV/PPQ activities and provide engineering run support.
• Collaborate cross-functionally with Process Development, Manufacturing, Engineering, Validation, Quality, and Supply Chain.

Skills

Process engineering

Technology transfer

Single-use systems

Risk management

GMP manufacturing

Cross-functional collaboration

Process characterization

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Syner-G BioPharma Group in Plainville, MA, is seeking an experienced Process Engineer to lead and support the transfer of manufacturing processes across development, clinical, and commercial sites.

The ideal candidate will have a strong background in process engineering, technology transfer, single-use systems, risk management, and GMP manufacturing, with extensive cross-functional collaboration across site functions and external partners.