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CSV Engineer

Company

PSC Biotech Corporation

Location

Singapore, Singapore

Posted

June 12, 2026

Position Overview

Job Description

  • Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
  • Perform risk assessments and impact analysis related to system validation.
  • Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
  • Manage change control and deviation investigations related to validated systems.
  • Support audits and inspections by regulatory authorities.
  • Maintain validation documentation and ensure traceability throughout the system lifecycle.

    • Requirements

  • Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
  • 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
  • Strong knowledge of GxP regul...

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