GMP Process Automation Engineer (Bioprocess)

F. Hoffmann-La Roche AG; Somerville (NJ); On-site; USD 77,000 - 143,000; Full time

Benefits offered by this job

Annual bonus

Job summary

Roche is hiring a Process Engineer to ensure robust automation, clean utility, and manufacturing processes across multiple Reagent Manufacturing laboratories and Site Operations.

You will perform CAPA, root cause investigations, and change control to maintain cGMP compliance, while supporting installation and commissioning of new systems and processes. The role requires collaboration with maintenance, engineering, and quality teams.

Qualifications

• Bachelor's degree in Engineering or related field; equivalent combination of education and experience accepted.
• 2+ years of process engineering and automation experience in a manufacturing setting; pharma/bioprocess exposure preferred.
• Experience performing root cause investigations and change control to maintain cGMP compliance.
• Cross-functional collaboration with maintenance, engineering, and quality teams to resolve issues.

Responsibilities

• Provide engineering support and troubleshooting for automation and Process Control System (PCS).
• Support cGMP Process Utility systems and equipment upgrades.
• Prepare and maintain documentation (Change Requests, SOPs, NCRs, URS, UAT).
• Assist in planning and design reviews of automation processes; conduct EHS reviews like HAZOP.
• Maintain high equipment reliability through maintenance and engineering resources.
• Contribute to instrumentation selection, wiring diagrams, issue diagnosis, and implementation.

Skills

PLCs

Industrial maintenance

Troubleshooting

Reading schematics

cGMP compliance

Team collaboration

Education

Bachelor's degree in Engineering or related field

Job description

Roche is hiring a Process Engineer to ensure robust automation, clean utility, and manufacturing processes across multiple Reagent Manufacturing laboratories and Site Operations.

You will perform CAPA, root cause investigations, and change control to maintain cGMP compliance, while supporting installation and commissioning of new systems and processes. The role requires collaboration with maintenance, engineering, and quality teams.