Csv Engineer

3 days ago


Singapore PSC BIOTECH PTE. LTD. Full time

Our esteemed client is seeking highly qualified and skilled CSV Engineers, both at the Senior and Junior levels, to provide essential support for routine and project-based Computer System Validation (CSV) activities. As a CSV Engineer, you will be instrumental in ensuring the compliance, reliability, and efficiency of computer systems utilized across diverse industries.

**Responsibilities**:

- Develop, review and/or approve validation lifecycle documents, strategies, plans and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion
- Manage qualification execution and lead validation deviation investigation encountered in qualification
- Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities
- Support Change Implementation on site
- Collaborate with Quality Engineering & Validation (QVCSV) and fellow Validation engineers in driving approvals of qualification / validation documentations and protocols, and handling deviations
- Any other tasks as and when assigned by Supervisor

**Requirements**:

- Bachelor's Degree of Elelctrical & Electronics Engineering or equivalent
- 5 years related experience in pharmaceutical environment
- Good understanding of Computer System Validation principles and GMP and regulatory requirements like GAMP5, ERES and Data Integrity
- Involved with some form of validation/qualification efforts of GMP computer systems and IT systems
- Good communication skills
- **Must be comfortable with cotract basis role


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