Cqv / Validation Engineer (Drug Substance & Drug Product)

Perform qualification and validation activities throughout the lifecycle of Drug Substance (DS) and Drug Product (DP) manufacturing facilities of equipment / systems from design through operational use and retirement. Ensure all validation activities are executed in compliance with applicable regulatory requirements, company standards, and industry best practices. Responsibilities: 1. General: Perform qualification and validation activities for the Drug Product and Drug Substance manufacturing facilities in Singapore. Ensure compliance with applicable regulatory requirements, company quality standards and validation procedures. Collaborate effectively with Engineering, Manufacturing, Quality, and external service providers to deliver validation objectives. 2. C&Q (Singapore Facilities Start-up) Develop and execute commissioning and qualification deliverables to support facility start-up and operational readiness. Coordinate C&Q activities with internal stakeholders, equipment suppliers, and external service providers. Review supplier-generated C&Q documentation and develop qualification protocols and reports where required. Participate in Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), as required. Track validation deliverables and project milestones to ensure timely completion in accordance with project schedules. Support the resolution of validation variance / issues in a timely and compliant manner 3. CQV (Singapore Facilities Operation) Maintain the qualified state of the equipment / systems through periodic review, re-qualification and continue process verification programs and change control system Support client audits, regulatory inspections, and internal audits by providing validation expertise and documentation Coordinate and execute qualification and validation activities supporting New Product Introduction, improvement projects, facility modification and shutdown activities Requirements: Diploma, bachelor's degree, or higher in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related discipline. Minimum 1 year of relevant validation experience. Experience working in facilities operating under FDA, EMA, EU GMP, PIC/S, or equivalent regulatory frameworks. Hands-on qualification of manufacturing equipment, cleanrooms, clean air devices, and temperature-controlled units. Experience performing smoke visualization studies, temperature mapping, or qualification using data loggers and mapping systems (e.g., Kaye, Ellab). is preferred. Basic knowledge and experience of regulatory requirements and industry standards. Good understanding of Quality System, EHS.