Automation Process Engineer for cGMP Manufacturing

Roche; Somerville (NJ); On-site; USD 92,000 - 172,000; Full time

Job summary

Roche in Branchburg, NJ is seeking a Process Engineer to ensure robust automation, clean utility and manufacturing processes. You will provide technical support to Reagent Manufacturing laboratories and Site Operations, driving CAPA, root-cause investigations, and change control in support of cGMP processes.

You will oversee installation and commissioning of new systems, maintain PCS, and collaborate with maintenance, engineering and quality teams to resolve availability and compliance issues

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related field.
• 3+ years of experience in process engineering and automation within manufacturing, including bioprocess/pharma/diagnostic site.
• Experience performing CAPA, root cause investigations, and change control to maintain cGMP compliance.

Responsibilities

• Lead engineering support and technical troubleshooting for automation systems, cGMP Process Utility systems, and equipment upgrades.
• Maintain and troubleshoot hardware and software for the Process Control System (PCS) handling Bulk Reagent Formulation, Solvent Delivery, Site, and Process Utility operations.
• Define scopes of work and supervise contract labor for small/medium projects supporting Branchburg Manufacturing and Utilities, including PCRW and lab water systems.
• Author and maintain system support and specification documentation (Change Requests, SOPs, Equipment Non-Conformances, URS, UAT).
• Manage plan/design review automation processes, including EHS reviews (e.g., HAZOP), equipment evaluations, tests, and approvals.
• Maintain high equipment reliability through maintenance, engineering, and resources to resolve availability issues.
• Participate in engineering projects involving instrumentation selection, wiring diagrams, issue diagnosis, and solution implementation addressing quality-related issues like CAPAs and audits.

Skills

PLCs

Maintenance engineering

Diagnostics

Schematic reading

Safety/compliance

Travel up to 10%

Lock Out Tag Out

Education

Bachelor’s degree in Engineering or related field

Tools

Process Control System (PCS)

Job description

Roche in Branchburg, NJ is seeking a Process Engineer to ensure robust automation, clean utility and manufacturing processes. You will provide technical support to Reagent Manufacturing laboratories and Site Operations, driving CAPA, root-cause investigations, and change control in support of cGMP processes.

You will oversee installation and commissioning of new systems, maintain PCS, and collaborate with maintenance, engineering and quality teams to resolve availability and compliance issues