ANTER CONSULTING PTE. LTD.
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.
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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.
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