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Csv Engineer

2 weeks ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

**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 cross-functional teams
- Must be team player, curious with strong analytical and organizational skills