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CSV Engineer

🏢
PSC Biotech Corporation
📍 Singapore, Singapore
📍
Location Singapore
📅
Posted May 27, 2026
🚗
Commute Local Area
🎯
Local Opportunity Near You!

This job is in your area. Enjoy a short commute and work close to home.

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Job Description

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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    📍 Location Details

    🌆
    City
    Singapore
    🗺️
    Country
    Singapore
    🚗
    Commute
    Local Area

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