Process Engineer

Process EngineerSummaryWe 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 cleanrooms, 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.Duties and ResponsibilitiesReview 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.Required Skills / AbilitiesStrong knowledge of GMP-regulated pharmaceutical or biotechnology manufacturing environments.Experience with commissioning, qualification, and validation of manufacturing equipment, clean utilities, HVAC systems, and cleanrooms.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 AssessmentsUser Requirements Specifications (URS)Functional SpecificationsFAT/SAT protocolsIQ/OQ protocolsCQV documentationExperience 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.Education and ExperienceBachelor’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.