About the Role:
We are seeking a skilled and driven Commissioning & Qualification (C&Q) Engineer to support our pharmaceutical clients on CAPEX projects across Singapore. You will play a key role in the qualification of critical systems, ensuring compliance with GMP and regulatory standards during facility and equipment commissioning.
Key Responsibilities:
- Develop and execute commissioning and qualification protocols (IQ/OQ/PQ) for process equipment, utilities, and cleanroom facilities.
- Review and verify design documentation such as URS, P&IDs, FAT/SAT reports, and as-built drawings.
- Perform risk assessments and impact assessments in line with GMP and ISPE guidelines.
- Coordinate with engineering, validation, QA, and vendor teams to ensure smooth execution of C&Q activities.
- Support change control, deviations, and CAPA related to C&Q scope.
- Assist in developing and maintaining the Validation Master Plan (VMP) and C&Q strategy.
- Participate in FAT/SAT and troubleshooting activities with vendors and site teams.
- Ensure all activities are documented in compliance with regulatory standards (e.g. FDA, EMA, PIC/S).
Requirements:
- Degree in Engineering, Life Sciences, or related field.
- Minimum 5 years of C&Q experience in the pharmaceutical or biotech manufacturing environment.
- Strong knowledge of GMP, FDA, and ISPE baseline guides.
- Hands-on experience in executing IQ/OQ/PQ for process equipment, HVAC, utilities, or lab systems.
- Excellent stakeholder management and communication skills.
- Familiarity with documentation and validation tools (e.g. TrackWise, Kneat) is a plus.
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