CSV Engineer

2 weeks ago

Boon Lay, Singapore PSC Biotech Full time $60,000 - $180,000 per year
Job Information

Date Opened

09/18/2025

Job Type

Contract

Industry

Pharma

City

Boon Lay Way

State/Province

South West

Country

Singapore

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 regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
  • Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
  • Excellent documentation and communication skills.
  • Ability to work independently and in cross-functional teams.

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