Senior Validation Engineer Equipment, Facilities & Utilities (EFU)

We are seeking experienced EFU Validation Engineers to join a high-profile biologics manufacturing project in Singapore. You will be responsible for ensuring all equipment, facilities, and utilities are qualified in compliance with cGMP, FDA, and PIC/S regulations.

Key Responsibilities

Execute Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for process equipment, clean utilities, and facilities.

Review and approve vendor turnover documentation, FAT/SAT reports, and as-built drawings.

Develop and approve validation protocols and summary reports.

Perform pre- and post-execution reviews of validation activities.

Support change control, deviation investigations, and risk assessments.

Act as validation SME during internal and regulatory audits.

Must-Have Requirements

Minimum 5 years of hands-on EFU validation experience in pharmaceutical or biologics manufacturing.

Direct experience with biologics downstream equipment (chromatography, filtration, centrifugation) and media/buffer preparation systems.

Strong knowledge of GMP, GAMP 5, 21 CFR Part 211, and EU Annex 1.

Experience with clean utilities (WFI, Pure Steam, HVAC) and facility qualification.

Excellent technical writing and documentation skills.

Must available immediately

6 Months contract (Rolling contract)

Must familiar installation qualification checks, vendor turnover document review. review/approve pre/post execution protocols (IQ,OQ, PQ protocols) for Facilities, Process Equipment. Qualification work experience of Biologic downstream equipment, media prep equipment and buffer prep equipment. (minimum 5 years experience) minimum 5 years relevant experience)