Senior Cqv Engineer

4 days ago

Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

**Responsibilities**:

- Lead commissioning, qualification, and validation (CQV) activities for equipment, utilities, and process systems.
- Start up and commission various process systems, equipment and utilities.
- 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 Client’s standard operation procedure (SOP).
- Ensure validation activities comply with cGMP, FDA, EMA, and ASTM E2500 guidelines.
- Implement approved protocols, identify non-conformances to User Requirements
- Write Requirements Traceability Matrix (RTM) for comments and acquire approval.
- Work closely with a multi-functional team not limiting to operations, QA and engineering.
- Maintain detailed documentation and provide regular updates to stakeholders.
- Write PQ protocols, issue for comments, and acquire pre-execution approval.
- Take lead and review project design documents (P&IDs, PFDs, URS etc.)
- Manage qualification execution and lead validation deviation investigation encountered in qualification.
- Ensure validation execution meets compliance, validation standards and cGMP requirements
- Review and comment pre-execution vendor commissioning protocols. Witness protocol execution. Ensure testing is complete and record test results in accordance with GDP.
- Any other task as assigned by Supervisor/Manager

**About You**:

- Diploma/Degree in Engineering or Science Disciplines with at least 5 years experience in Pharmaceutical Industry
- Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV)
- In-depth knowledge on cGMP, GDP and ASTM E2500
- Proactive and self-motivated
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations)
- Effective Project Management, leadership, communication and interpersonal ski

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