Senior Validation Engineer – Equipment, Facilities
ONE STOP MANAGEMENT SERVICES PRIVATE LIMITEDJob Description
Job Description & Requirements
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. ...
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