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.