Process Engineer

Roche; 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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As the Process Engineer, you will ensure robust automation, clean utility, and manufacturing processes by providing technical support to multiple Reagent Manufacturing laboratories and Site Operations. You will carry out CAPA, root cause investigations, process improvements, and change control practices in support of cGMP processes. In this role, you will participate in the installation and commissioning of new systems, and processes.

The Opportunity

• You will provide engineering support and technical troubleshooting for automation systems, cGMP Process Utility systems, and general equipment upgrades
• You will troubleshoot hardware and software for the Process Control System (PCS), which controls Bulk Reagent Formulation, Solvent Delivery, Site, and Process Utility operations
• Author and maintain system support and specification documentation, including Change Requests, SOPs, Equipment Non-Conformances, User Requirements Specifications, and User Acceptance Testing
• Contribute to the planning and design review of automation processes, including EHS reviews (e.g., HAZOP), equipment evaluations, tests, and approvals
• Maintain high equipment reliability utilizing maintenance, engineering, and appropriate resources to resolve availability issues
• Participate in engineering projects involving instrumentation selection, wiring diagram generation, issue diagnosis, and solution implementation while addressing quality-related issues like CAPAs and audits.

Who You Are

• You have a Bachelor’s degree in Engineering, Computer Science, or a related field (or an equivalent combination of education and work-related experience)
• You have 2+ years of experience with increasing responsibilities in process engineering and automation within a manufacturing environment, including at least 1 years in a bioprocess, pharma, or diagnostic site
• You will carry out root cause investigations and execute change control practices to maintain cGMP compliance
• You will collaborate across maintenance, engineering, and quality teams to resolve equipment availability and compliance issues.

Preferred Qualifications

You have experience with the design and operation of cGMP clean utility systems and manufacturing equipment (e.g., Purified Water Generation/Distribution, Clean Steam, CIP, Autoclaves, Glass Washers, and Manufacturing Process Vessels).

Knowledge, Skills And Abilities

• Solid understanding of mechanical systems, including valves, pumps, motors, seals, and bearings
• Experience with PLCs, industrial maintenance, and computer control systems
• Strong diagnostic, problem-solving, and troubleshooting skills for hardware and software systems
• Ability to read and interpret schematics, including P&IDs, mechanical, electrical, and control diagrams
• Willingness and ability to fulfill operational work environment requirements, including wearing required PPE, performing Lock Out Tag Out, climbing ladders, and maintaining a valid driver's license
• Flexibility to carry a company-issued cell phone for off-hours response, work weekends during facility shutdowns (4 times per year), and perform overtime as needed

Willingness to travel up to 10%.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Branchburg, NJ is 77,100.00 - 143,100.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.