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Associate CSV Engineer


  • 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.

About You:

  • Diploma / Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls.

  • Min. 1 year' experiences in CSV preferably in biotech facility. Fresh graduates welcome to apply.

  • 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

  • Must be team player, curious with strong analytical and organizational skills

Submit your resume to
Only shortlisted candidates will be contacted. 
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