Csv Engineer
3 days ago
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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