Project/Site Engineer

Job Title : Project/Site Engineer -- GxP - MADuration: 1 Year + Extension Start: After JuneWork Model: On-site, 5 days/weekResponsibilitiesProvide day-to-day engineering support for GMP manufacturing facilities, utilities, and process systems.Author, execute, and manage change controls, deviations, CAPAs, and related GMP documentation.Support commissioning, qualification, and validation activities including FAT, SAT, IQ, OQ, and PQ.Review and update engineering documentation including P&IDs, specifications, as-built drawings, and redlines.Troubleshoot equipment and system issues and support planned shutdown and maintenance activities.Coordinate with vendors, A&E firms, subcontractors, and cross-functional manufacturing teams.Support inspection readiness activities and participate in FDA/EMA audit preparation.Maintain compliance with GMP, quality, and regulatory standards across all engineering activities.QualificationsBachelor’s degree in Chemical, Mechanical, Electrical, or related Engineering discipline.4+ years of experience in regulated pharmaceutical, biotech, or biopharma manufacturing environments.Hands-on experience with CQV documentation including URS, FS, FAT/SAT, IQ/OQ/PQ, impact assessments, and traceability matrices.Experience authoring and executing change controls within regulated quality systems.Familiarity with cleanroom environments (ISO 8/7/5), BMS, EMS, SCADA, and CMMS platforms.Strong understanding of GMP documentation practices and validation standards.Preferred experience with cell & gene therapy, aseptic fill-finish, FDA/EMA inspections, Kneat, ValGenesis, GAMP, 21 CFR Part 11, and Annex 11.