Validating Computer Systems Specialist

2 weeks ago

Singapore beBeeValidation Full time $80,000 - $120,000
Computer System Validation (CSV) Engineer Position

We are seeking a skilled Computer System Validation (CSV) Engineer to support QC and laboratory operations in a regulated environment.

Main Responsibilities
  • Validate QC systems such as LIMS, Empower, CDS, and other analytical equipment.
  • Author and execute CSV deliverables including 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 of experience in CSV within the pharmaceutical or biotechnology industry.
  • Hands-on experience with laboratory systems validation.
  • Strong knowledge of cGMP, GAMP 5, and Annex 11 guidelines.
  • Experience supporting audits and regulatory inspections.
  • Strong documentation and stakeholder collaboration skills.
Industry Expertise
  • Pharmaceutical Manufacturing
  • Quality Assurance
  • Biotechnology
  • Computer System Validation
  • LIMS
  • Audits
  • Biopharmaceuticals

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