CSV Engineer

3 days ago


Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

We are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while supporting continuous improvement initiatives.

Key Responsibilities

  • Perform validation of QC systems such as LIMS, Empower, CDS, and other analytical equipment.
  • Author and execute CSV deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, Summary Reports).
  • Manage system lifecycle activities, including change controls, periodic reviews, and data integrity assessments.
  • Ensure audit and inspection readiness for CSV documentation.
  • Contribute to error-reduction and continuous improvement activities within QC operations.

Requirements

  • 5 years' experience in CSV within the pharmaceutical or biotechnology industry.
  • Hands-on experience with laboratory systems validation.
  • Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.
  • Experience supporting audits and regulatory inspections.
  • Strong documentation and stakeholder collaboration skills.

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