Senior Process Engineer (Sterile & High-Purity Process Systems)
Location: Rahway, NJ (Onsite)
Industries: Biopharma
Full-Time | Engineering Design & CQV
We are looking for a Senior Process Engineer to lead high-impact projects across the bio-pharmaceutical, personal care, and food sectors.
As a technical leader, you'll deliver end-to-end solutions for integrated process equipment and unit operations in GMP environments, from early design through CQV.
Lead conceptual, preliminary, and detailed process designs
Develop deliverables such as:
Feasibility studies, mass balances, utility sizing
Process simulations, PFDs, P&IDs, control strategies
URS, FDS, equipment specs, cost estimates
Bid packages, commissioning and qualification protocols
Guide projects from front-end engineering through start-up and CQV
Oversee equipment and utility design (e.g., fermenters, TFF, CIP systems)
Collaborate with controls, validation, and QA teams
Mentor junior engineers and support proposal development
Maintain strong client relationships and lead multi-functional teams
8+ years in GMP process engineering, ideally with skidded systems
Experience in process equipment and piping system design
Commissioning & qualification experience (automated systems preferred)
Familiarity with CAD, process control, and validation coordination
Strong communication, organization, and leadership skills
Comfortable in a fast-paced, multi-project environment
This role offers true engineering creativity with exposure to a wide range of exciting, complex projects in a collaborative and technical environment.
#ProcessEngineering #PharmaJobs #Biotech #CQV #GMP #EngineeringCareers
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