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CSV Engineer

2 months ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Job Title: CSV Engineer

About the Role:

The CSV Engineer will be responsible for managing the Computer System Validation Lifecycle from design to execution phases. This includes relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols.

Key Responsibilities:

  • Manage CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols.
  • Perform troubleshooting during test execution.
  • Responsible for execution of thermal mapping activities.
  • Write execution related deviations and change requests.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.

Requirements:

  • Diploma/Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls.
  • Min. 3 years of experience in CSV preferably in a biotech facility.
  • Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP)
  • Familiar with Health Authorities standards (e.g., FDA CFR and EU)
  • Knowledge of thermal mapping validation and usage of data logger is a plus.
  • Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams

What We Offer:

06 months contract with option to extend/convert subject to performance review.