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SkyWater Search Partners

Senior Process Engineer

SkyWater Search Partners, Fairfield, New Jersey, us, 07004

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Get AI-powered advice on this job and more exclusive features. Were seeking a Process Engineer with experience designing and supporting sanitary process systems for regulated environments such as biopharma, food, or beverage manufacturing. In this role, youll lead engineering workstreams from concept through commissioning, helping build and validate custom stainless-steel and/or single-use systems like bioreactors, fermentation tanks, and CIP/SIP skids. Responsibilities Develop PFDs, P&IDs, and equipment specifications for integrated processing systems Perform mass & energy balances and size equipment (vessels, heat exchangers, pumps, etc.) Collaborate with sales, fabrication, controls, and QA to bring complex projects to life Support automation integration (PLC/SCADA), FAT/SAT testing, and field commissioning Ensure compliance with industry standards such as ASME BPE, FDA, and cGMP Contribute to validation protocols (IQ/OQ/PQ) and continuous improvement efforts Document technical changes, system specs, and test results to support regulated manufacturing Qualifications B.S. or M.S. in Chemical, Mechanical, or Bioprocess Engineering 47 years in process or project engineering roles in biopharma, CDMO, or sanitary system design Strong understanding of cGMP and regulated manufacturing environments Skilled in CAD tools (AutoCAD or SolidWorks); experience with SuperPro or Aspen is a plus Familiarity with validation processes, risk assessments (FMEA/HAZOP), and scale-up strategies Strong communication and project coordination skills Preferred Experience (not Required) Familiarity with Allen-Bradley or Siemens controls Experience with single-use assemblies or modular skid systems Exposure to FDA/EMA/USP documentation and audits Travel Up to 20% for customer site visits, commissioning, and vendor coordination Seniority level

Seniority level

Mid-Senior level Employment type

Employment type

Full-time Job function

Job function

Manufacturing, Engineering, and Project Management Industries

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