Process Validation Engineer - MSAT / Biopharma
Amaris Consulting • singapore, singapore • Posted June 23, 2026
Position Overview
Responsibilities
- Support and execute technology transfer for drug substance manufacturing
- Drive scale‑up activities from lab to commercial production
- Collaborate with cross‑functional teams to ensure smooth implementation
- Develop and optimize processes including purification, homogenisation, and cleaning processes for routine operations
- Provide technical guidance to site teams
- Lead and support validation activities including cleaning validation, water mixing validation, and risk assessments (e.g. extractables & leachables – E&L)
- Ensure compliance with GMP and regulatory standards
- Prepare and review validation protocols, reports, and technical documentation
- Support integration of single‑use systems and new manufacturing equipment
- Experience in commercial‑scale GMP manufacturing (biologics drug substance)
- Strong background in tech transfer and...