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.

1. 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

1. 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.