Senior Process EngineerJob Summary:The Process Engineer supports capital project execution, engineering design, and ongoing improvements to systems and equipment within pharmaceutical and life sciences facilities operating under cGMP requirements.
This role provides technical expertise across the full project and system lifecycle, from scope development and documentation through implementation, commissioning, qualification, and ongoing optimization. The engineer works on both greenfield builds and capital projects within operating facilities, in collaboration with engineering design, construction management, and CQV/start-up teams.
Candidates without direct pharmaceutical experience will need to demonstrate clearly transferable experience in regulated manufacturing environments, such as critical utility systems, cleanrooms, or process equipment.
Responsibilities:- Execute capital projects on greenfield builds and within operating facilities, from scope development through implementation, commissioning, and qualification. Coordinate with design, construction, and CQV/start-up teams to move projects from approved design to handover. Support or perform design work as needed, including technical documentation and deliverables.
- Work independently while asking questions early and drawing on the best internal, client, and industry resources to meet requirements accurately and efficiently. Build and maintain long-term professional relationships with coworkers, clients, suppliers, and industry partners. Maintain composure under pressure.
- Develop and maintain project documentation, including specifications, test plans, and progress reports. Analyze data and report results clearly. Manage documentation within cGMP-controlled systems, including validation and change control processes.
- Communication:
- Keep clients, contractors, and project teams informed, in person and in writing, on scope, deliverables, and compliance requirements, at technical through executive levels. Ensure timely, accurate information transfer in controlled documentation environments. Proactively raise issues, risks, and knowledge gaps, and take ownership of closing communication gaps with the client.
- Innovation:
- Foster an environment where new ideas are discussed and developed collaboratively and help others work through resistance to change. Create practical solutions to client problems.
Qualifications and Experience:- Education: Bachelor's degree in engineering (Chemical, Mechanical, or equivalent preferred)
- Experience: >5 years working in pharmaceutical industry or relevant regulated industry.
- Technical Skills:
- Direct hands-on experience in cGMP regulated environments in clean utilities, process equipment, maintenance/reliability or manufacturing systems, and an understanding of how engineering activities integrate with controlled documentation, validation, and change control processes.
- Experience developing and interpreting engineering deliverables, including PFDs, P&IDs, equipment specifications, system design documentation, and CQV documentation.
- Experience supporting capital projects within operating facilities, including system upgrades, expansions, or process improvement.
- Familiarity with engineering principles including fluid flow, heat transfer, mass balance, and pressure safety, applied in the context of real-world system design and operation.
- Adaptability: Flexibility and willingness to work on various projects and tasks, embracing new challenges with enthusiasm.
- Initiative: Demonstrated ability to work independently and take initiative to drive projects forward.
- Proficiency in using engineering tools and software platforms.
Location: This is not a remote role. This position will be required to report to a client site in Raleigh, NC.
Travel: Flexibility and willingness for travel based on project needs.
Compensation: $70,000-$170,000
Benefits:Actual compensation will be determined based on a number of factors including skills, experience, qualifications, and location. This role is also eligible for performance-based bonuses, and a comprehensive U.S. based benefits package, including:
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off and company holidays
- Wellness programs and employee assistance resources
- Professional development support
For more information, visit our full benefits overview here.
