Senior CQV Engineer

• Generate and implement validation life cycle documentation such as site acceptance test (SAT), system risk assessment (SRA), design qualification (DQ), installation and operation qualification (IOQ), qualification summary report (QSR) and deviation report for process and utilities equipment as per Thermofisher standard operation procedure (SOP).
• Implement approved protocols, identify non-conformances to User Requirements
• Write Requirements Traceability Matrix (RTM) for comments and acquire approval.
• Review and comment pre-execution vendor commissioning protocols. Witness protocol execution. Ensure testing is complete and record test results in accordance with GDP.
• Write PQ protocols, issue for comments, and acquire pre-execution approval.
• Support compute system validation activities.
• Work closely with a multi-functional team not limiting to manufacturing and quality assurance.

Education:

• An engineering degree with no less than 5 years working as a CQV engineer in a pharmaceutical industry.

Experience:

• Extensive knowledge of validation activities including plan and protocol generation, execution, final report approval/closeout and change control.
• Proficient with computers (MS office). Shown understanding of controlled documentation and data systems.