Process Engineer

We are seeking experienced Process Engineers to support capital projects, facility modifications, equipment installations, commissioning activities, lifecycle documentation, and engineering deliverables within GMP-regulated pharmaceutical and biotechnology environments. This role will support manufacturing clean rooms, laboratories, utilities, warehouses, and facility systems while collaborating cross-functionally with Engineering, Validation, Quality, Facilities, and Operations teams.

The ideal candidate will have strong experience in commissioning, qualification, validation, engineering documentation, and GMP facility support within regulated manufacturing environments.

• Review engineering design packages and vendor submittals for compliance with operational, maintenance, and regulatory requirements.
• Develop, review, and update technical specifications for equipment and facility systems.
• Provide engineering oversight during design, fabrication, installation, startup, and commissioning activities.
• Coordinate activities with vendors, contractors, architects, engineers, and internal stakeholders.
• Support schedule reviews, risk assessments, and mitigation planning activities.
• Author, execute, review, and manage change controls in accordance with GMP and quality requirements.
• Review and update engineering drawings, P&IDs, SOPs, technical documentation, and as-built drawings.
• Support commissioning and qualification activities including FAT, SAT, IQ, OQ, and related protocols.
• Partner with Validation and Quality teams to ensure systems meet compliance and operational readiness requirements.
• Support deviation investigations, CAPAs, inspection readiness activities, and continuous improvement initiatives.
• Troubleshoot manufacturing, utility, and facility systems to support ongoing operations.
• Support startup, shutdown, impairment, and transition activities during project execution.
• Participate in operational, project, and cross-functional coordination meetings.
• Provide timely project updates, documentation, and status reporting.

• Strong knowledge of GMP-regulated pharmaceutical or biotechnology manufacturing environments.
• Experience with commissioning, qualification, and validation of manufacturing equipment, clean utilities, HVAC systems, and clean rooms.
• Ability to read and interpret engineering drawings, P&IDs, specifications, equipment manuals, and vendor documentation.
• Knowledge of FDA and EU regulatory requirements including 21 CFR Part 11, Annex 1, GMP, GEP, ISO, GAMP, USP, ASME BPE, ISA, and ANSI standards.
• Experience creating and managing lifecycle documentation including:
• Impact Assessments
• User Requirements Specifications (URS)
• Functional Specifications
• FAT/SAT protocols
• IQ/OQ protocols
• CQV documentation
• Experience managing change controls, deviations, and CAPAs within GMP environments.
• Familiarity with cleanroom classifications (ISO 5/7/8 and Grade A/B/C/D environments).
• Experience with CMMS, BMS, EMS, and SCADA systems preferred.
• Strong technical writing, communication, and cross-functional collaboration skills.
• Ability to gown and work within cleanroom and aseptic manufacturing environments.

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related discipline) required.
• Minimum of 4+ years of experience within pharmaceutical, biotechnology, or other regulated manufacturing environments.
• Experience supporting site engineering, facilities engineering, process engineering, CQV, or validation activities in GMP environments required.
• Experience with manufacturing equipment, clean utilities, facility systems
  , and startup/qualification activities strongly preferred.