Validation Engineer

anter consulting pte. ltd. · singapore, singapore, Singapore

Location
singapore
Job Type
Full-time
Posted
June 16, 2026

Job Description

We are looking for Validation Engineers to lead the commissioning, qualification, and validation of critical facility systems (HVAC, cleanrooms, process gases) and manufacturing software (GAMP 4/5) to ensure full compliance with FDA 21 CFR Part 11, GAMP 5, and ISO 14644 standards in Singapore. Key Responsibilities Validation Lifecycle: Author and execute VMP, CMP, URS, FDS, and IQ/OQ/PQ protocols for manufacturing equipment and software applications. Systems & Software Qualification: Qualify critical utility systems (HVAC, BMS, EMS, Process Gases) and validate software systems, upgrades, and PLC-driven automation. Vendor & Project Coordination: Manage and witness vendor testing and commissioning (T&C) activities. Regulatory Compliance: Ensure all computerized systems meet strict data integrity guidelines and regulatory audit readiness.
Job Requirements - Degree in Engineering (Electrical, Biochemical, or related). - 4+ years of CQV/CSV experience in life sciences, medical devices, o...

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