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Junior Csv Engineer

3 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.

**Requirements**:

- Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls.
- Min. 1-2 years' 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.
- Fresh graduate is welcome to apply.

Contract length: 6 Months (Option to extend pending performance and business needs).

**Job Type**: Contract

Location: Tuas

**Job Types**: Full-time, Contract
Contract length: 6 months

**Salary**: $3,000.00 - $4,000.00 per month

Schedule:

- Monday to Friday

COVID-19 considerations:
All staff to observe MOH regulations and practices.

**Education**:

- Bachelor's or equivalent (preferred)

**Experience**:

- Biopharmaceutical Industry: 1 year (preferred)