Location: Tuas, Singapore
Contract Position
About our client
Our client is proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings out the best in our personnel, and helps us develop innovative solutions that contribute to building a better world together. If this sounds like a culture you would like to work in, you are invited to apply for this role.
An exciting opportunity has arisen to join a major pharmaceutical manufacturing project in Singapore. This role will support the delivery of a new state-of-the-art manufacturing facility for advanced biologics production on a greenfield site.
As a C&Q Execution Lead Engineer, you will be responsible for leading the execution of Commissioning, Qualification and Validation (CQV) activities within your assigned area, ensuring compliance, safety, quality, and schedule objectives are achieved. You will coordinate multidisciplinary teams and act as the owner's representative for commissioning activities executed by EPCM contractors, vendors, and service providers.
Key Responsibilities
- Lead commissioning and qualification execution activities from Mechanical Completion through to system handover.
- Execute CQV activities in accordance with approved execution plans, validation strategies, and GMP requirements.
- Support FAT preparation, witnessing, and package readiness activities for equipment sourced globally.
- Coordinate commissioning teams, vendors, calibration teams, temperature mapping specialists, and other support resources.
- Participate in Mechanical Completion walkdowns and readiness reviews.
- Prepare and support commissioning documentation including LOTO plans, RAMS, PSSR, permits, and method statements.
- Lead system start-up, energisation, set-to-work, shakedown, and performance testing activities.
- Troubleshoot mechanical, electrical, control system, and process performance issues during commissioning.
- Execute and support IV, OV and PQ activities, including protocol execution and exception management.
- Ensure all documentation complies with GDP and ALCOA+ principles.
- Drive completion of deficiencies, punch list items, and remediation activities.
- Provide regular status updates, schedule tracking, and escalation of critical issues.
About You
- Bachelor's degree in chemical, Mechanical, Process Engineering or a related discipline.
- 10+ years of experience within Commissioning, Qualification and Validation environments.
- Strong pharmaceutical, biotechnology, life sciences, or GMP manufacturing project experience.
- Hands-on field CQV execution experience across complex process and utility systems.
- Experience commissioning and qualifying:
- Upstream & Downstream Processing Systems
- Media and Buffer Systems
- CIP/SIP Systems
- Utility and Process Systems controlled through DCS and PLC platforms
- Knowledge of Risk-Based Validation methodologies and current GMP regulations.
- Excellent communication and stakeholder management skills.
- Strong problem-solving ability and a proactive approach to execution challenges.
Highly Desirable
- PMP or equivalent project management certification.
- Experience working in high-containment or potent compound manufacturing facilities.
What's on Offer?
- Opportunity to work on a large-scale, cutting-edge pharmaceutical manufacturing facility.
- Collaborative international project environment.
- Exposure to advanced biologics manufacturing technologies.
- Long-term project involvement with a highly experienced project delivery team.
If you have extensive CQV execution experience within pharmaceutical or biopharmaceutical facilities and are looking to contribute to a landmark project in Singapore, we would like to hear from you.
We are an equal opportunity employer. All qualified individuals will receive consideration for employment without regard to race; color; age; sex; sexual orientation; gender identity; religion; national origin; disability; veteran status; genetic information; or any other criteria protected by governing law.
