• Job Tag: #LI-CF1
• Posted: July 18,2025

We’re 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, you’ll 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

• 4–7 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):

• Lean Six Sigma certification

• 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