Process Engineer

Position OverviewWe are seeking a highly competent and adaptable Project Engineer / Consultant to support critical engineering, commissioning, and validation initiatives for our life sciences and regulated manufacturing clients. The ideal candidate will possess deep expertise in facility startups, plant utilities, and cGMP HVAC systems, alongside a strong consultative mindset. This role requires an individual who can seamlessly pivot from high-level technical design sessions to hands-on equipment qualification and field-side troubleshooting on-site at client locations.Key ResponsibilitiesSystem Design & Consultation: Participate in and lead technical sessions related to HVAC and building mechanical system engineering and design. Develop practical, innovative solutions to complex engineering challenges.Utility & Facility Startup: Lead and support startup activities for plant utility systems, including Black Utilities (chilled water, plant steam), Clean Utilities (WFI, Clean Steam), and operational waste/air systems.Commissioning & Qualification (C&Q): Execute the full C&Q lifecycle for complex utility and facility systems. Develop and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols.Vendor & Construction Coordination: Coordinate and support vendor startup activities, including Site Acceptance Testing (SAT). Bridge the gap between engineering and validation by supporting transitions from construction completion to formal commissioning.Field Verification: Perform comprehensive field walk-downs and execution of P&ID redlining to ensure absolute "as-built" accuracy during system transitions.Regulatory Compliance: Ensure all HVAC, mechanical, and utility systems strictly comply with current Good Manufacturing Practices (cGMP) and applicable regulatory standards.Technical Documentation: Develop, review, and maintain rigorous project documentation, including Standard Operating Procedures (SOPs), user requirements specifications, testing protocols, final summary reports, and field turnover packages.Cross-Functional Collaboration: Partner with cross-functional client teams to lead and drive key project workstreams, ensuring high-quality, on-time project deliverables.Minimum QualificationsEducation: Bachelor’s Degree in Life Sciences, Engineering, or a related technical discipline (or an equivalent combination of formal education and relevant industry experience).Experience: 5+ years of proven experience operating as a Project Engineer, Engineering Consultant, or in a closely related technical role within a regulated manufacturing environment.Technical Expertise: Hands-on experience supporting HVAC systems, utility engineering, and cGMP facility startups.Systems Fluency: Direct experience working with both Black Utilities (chilled water, plant steam) and Clean Utilities (WFI, Clean Steam).Classified Spaces: Proven knowledge in the design, installation, and qualification of cGMP HVAC systems supporting classified cleanroom spaces (including cascading pressure, filtration, single-pass, and monitored environments).Industry Standards: Strong familiarity with ASTM E2500 and/or ISPE Baseline Guides for Commissioning and Qualification.Operational Readiness: Ability to work full-time on-site at client facilities, with strong problem-solving skills and a high level of attention to detail in field execution and documentation.Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a clientTo read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records.