Process Engineer – Clean/Black Utilities

Position Summary

Process Engineer Clean/Black Utilities is responsible for the design, installation, commissioning, and lifecycle support of clean and black utility systems supporting GMP pharmaceutical manufacturing operations. This role plays a critical part in capital project delivery, ensuring utility systems meet process, quality, regulatory, and operational requirements from concept through start-up and ongoing optimization.

Key Responsibilities

• Lead engineering design and execution for utility systems including Water for Injection (WFI), Purified Water (PW), Clean Steam, Pure Steam, Plant Steam, Compressed Air, Process Gases (N2, O2, CO2), HVAC support utilities, Chilled Water, and Heating/Cooling loops.
• Develop and review user requirement specifications (URS), functional specifications, P&IDs, PFDs, equipment datasheets, and design calculations.
• Perform hydraulic, thermal, and capacity calculations to size piping, pumps, heat exchangers, and storage/distribution systems.
• Collaborate with architects, MEP engineers, and EPCM partners on facility layout, equipment placement, and utility distribution.
• Support vendor selection, technical bid evaluations, FAT/SAT execution, and commissioning of utility skids and distribution loops.
• Author and review engineering deliverables including specifications, calculations, design basis documents, and Turn-Over Packages (TOPs).
• Partner with Validation and C&Q teams to develop and execute IQ/OQ/PQ protocols for utility systems.
• Identify and implement continuous improvement opportunities for energy efficiency, reliability, and compliance.
• Ensure designs comply with cGMP, ASME BPE, ISPE Baseline Guides, FDA, EMA, USP, and applicable safety codes.

Required Qualifications

• Bachelor's degree in Chemical, Mechanical, or related Engineering discipline.
• 3–7 years of experience in pharmaceutical, biotech, or related GMP-regulated manufacturing environment.
• Hands-on experience designing or supporting clean utility systems (WFI, PW, Clean Steam) and black utilities.
• Proficiency in reading and developing P&IDs, isometrics, and engineering drawings.
• Demonstrated experience with capital project execution from FEED through start-up.

Preferred Qualifications

• Master's degree in Engineering or related field.
• PE license (or in progress).
• Experience with single-use, sterile fill-finish, biologics, or oral solid dose facilities.
• Familiarity with Delta V, Siemens PCS 7, or equivalent DCS platforms.
• Experience with Lean, Six Sigma, or operational excellence programs.

Technical Skills

• AutoCAD, Navisworks, SmartPlant, or comparable 2D/3D design tools.
• Process simulation tools (Aspen, SuperPro, or equivalent) a plus.
• Microsoft Project, Primavera P6, and MS Office suite.

Why Join Us

• Work on greenfield and brownfield capital projects supporting next-generation therapeutics.
• Exposure to cutting-edge process technologies, single-use systems, and advanced automation platforms.
• Collaborative, safety-first, quality-driven culture committed to patient outcomes.

Equal Opportunity Employer

Hydrogen Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

...