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Open nowPosted 7 days ago

CQV / Validation Engineer (Drug Substance & Drug Product)

MyCareersFuture94,028 open roles

Pay
SGD 4,500 – SGD 8,000 a month
Where
Singapore
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Your applicationOpen nowCQV / Validation Engineer (Drug Substance & Drug Product)MyCareersFuture · Singapore

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The clock on this job

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7.7% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
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  2. 3.3%3 days
  3. 7.7%7 days
  4. 14.0%14 days
  5. 33.7%30 days
This job: posted 7 days ago

The posting

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.
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