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Csv Engineer

2 weeks ago

Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

**Position: CSV Engineer**

We are currently expanding our team and are looking for a **CSV Engineer**to support projects on site with a client.

In summary, you will be responsible for managing all computer systems validation activities including, but not limited to, drafting, reviewing, and approving all CSV-related activities, as well as conducting deviation investigations, and working alongside the teams that provide QA oversight to ensure consistent compliance of cGMP standards.

**Key Responsibilities**:

- Provides expertise in performing Computerized Systems Validation.
- Collaborate with validation and tech support teams in other sites to ensure a consistent and cohesive approach.
- Conduct deviation investigations, identification and completion of corrective and preventative actions.
- Supervise contractors, engineers and provide day to day support to operations including, modifications and changes to processes and equipment, and troubleshooting activities.
- Ensure timely completion of all validation related activities including computer system, equipment, utilities, and facility with compliance.
- Perform assessment of vendor documents for CSV deliverables.
- Analyse business trends, and propose solutions to issues that can potentially impact the validation status of GMP equipment.

**Requirements**:

- Degree in Science or Engineering or any other related qualifications.
- Familiar with government code of practice, regulations, current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP).
- At least 5 years of experience in to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

**What’s In It for You?**
- Exposure to the major Pharmaceutical Companies in the industry.
- Annual leave benefits.
- Full Health coverage and benefits.
- Training and Development allowance.

**What's Next?