Pharma Process Engineer

We are seeking experienced Principal Process Engineers to support a large-scale greenfield biologics manufacturing project.
This role is focused on process system ownership across design, build, startup, and early operations.
The ideal candidate is not CQV-heavy and should have strong experience defining requirements, supporting system design, and owning process equipment end-to-end.
The candidate will serve as a Process Systems Owner / SME for assigned GMP manufacturing areas.
Key areas include downstream processing, clean utilities, upstream support, and process support equipment.
The highest priority is downstream processing equipment such as chromatography systems, AKTA skids, columns, UF/DF skids, depth filtration, nano filtration, sterile filtration, centrifuges, product hold tanks, buffer hold tanks, formulation systems, and mixing vessels.
Other systems may include CIP, valve arrays, in-line dilution skids, caustic systems, process gases, washers, autoclaves, freezers, cold rooms, SIP systems, media prep systems, and buffer prep systems.
The engineer will partner with A&E firms, EPCM teams, equipment vendors, automation teams, manufacturing, quality, and engineering groups.
Responsibilities include supporting process design, equipment selection, system integration, technical reviews, and startup readiness.
The role requires the ability to translate process needs into URS, FRS, design inputs, and technical requirements.
The engineer will review P&IDs, equipment specifications, utility requirements, layouts, vendor documents, and system design details.
Hands-on troubleshooting experience with complex GMP process systems is required.
DeltaV experience is required from a user troubleshooting or operations support perspective, but this is not an automation engineer role.
The candidate should be comfortable supporting batch execution issues, alarms, recipes, interlocks, and process sequence concerns by working with automation teams.
Experience in greenfield, brownfield, capital project, construction-driven, or large-scale GMP facility environments is strongly preferred.
A bachelor’s degree in an engineering discipline is required.
Lean, Six Sigma, advanced degree, or prior experience supporting technology transfer and fit-to-plant activities is preferred.
Success in this role requires strong communication, technical leadership, vendor coordination, cross-functional collaboration, and the ability to drive accountability across multiple stakeholders.