Csv Engineer - Singapore - NUSANTARA PRIME CONSULTING PTE. LTD.

NUSANTARA PRIME CONSULTING PTE. LTD.
NUSANTARA PRIME CONSULTING PTE. LTD.
Verified Company
Singapore

1 week ago

Wei Jie

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Wei Jie

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Description

Responsibilities:


  • Manage Computer System Validation Lifecycle from design to execution phases; Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols.
  • Responsible for preparation of 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.
  • Any other task as assigned by Supervisor/Manager.

Requirements:


  • Diploma / Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls.
  • Min. 3 years of experiences in CSV preferably in 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 crossfunctional teams
  • Must be team player, curious with strong analytical and organizational skills
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