Validation Engineer

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

1. Validation Lifecycle: Author and execute VMP, CMP, URS, FDS, and IQ/OQ/PQ protocols for manufacturing equipment and software applications.
2. Systems & Software Qualification: Qualify critical utility systems (HVAC, BMS, EMS, Process Gases) and validate software systems, upgrades, and PLC-driven automation.
3. Vendor & Project Coordination: Manage and witness vendor testing and commissioning (T&C) activities.
4. 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, or pharmaceutical manufacturing.

- Strong knowledge of 21 CFR Part 11, GAMP 5, ISO 14644, and validation software like KNEAT.