Senior Project Engineer

About the Role:

We are seeking a skilled and driven Senior Project Engineer to support 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 10 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.