Project​/Site Engineer

Duration: 1 Year + Extension

Start:
After June

Work Model:
On-site, 5 days/week

• Provide 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.

• Bachelor’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, Val Genesis, GAMP, 21 CFR Part 11, and Annex 11.