Senior Computer System Validation
5 days ago
**Roles & Responsibilities**
The Senior Computer System Validation (CSV) Engineer will be based in one of clients who is among the top tier pharmaceutical giants. The engineer will provide a wide range of support for GMP Computerized System and Data Integrity Activities at site.
**Responsibilities**
- Coordinate/manage multiple small and large CSV/Data Integrity projects simultaneously
- Execution of CSV/Data Integrity activities associated with GMP manufacturing and laboratory instruments/equipment, utilities, and facilities
- Coordinate meetings with multiple stakeholders both internal and external, to drive project progress, deliverables discussion, facilitate decisions, capture meeting minutes/action lists, provide timely updates
- Familiarity with ISA 88/ 95 Standards for automation system
- Develop and review the change control proposals and drive the change management process
- Prepare/Review System Development Life Cycle (SDLC) documents, like User Requirements Specifications (URS), Functional Design Specifications (FDS), Requirements Specifications (RS), Software Design Specifications (SDS), Detailed Design Specifications (DDS), System Architecture, Requirements Traceability Matrix (RTM), Access Matrix, Alarm Matrix
- Prepare/Review Project Master Plan, Quality Assurance Plan (QAP), Quality Assurance Summary Report (QASR)
- Review and approve vendor commissioning documents (FAT, SAT)
- Prepares and execute IQ, OQ, PQ, Test Protocols, ensuring documentation meets required regulatory standards
- Develops and update SOPs, Job Aids and Work Instructions at site
- Develops and updates Automation training packages, and conducts Automation training
- Provide hyper care support post system release for deviation and operation investigation
- Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning /qualification phases
- Perform any other duties as assigned by the Supervisor
**Requirements**:
- Minimum 5-7 years’ relevant working experience in pharmaceutical/Biotech industry
- Bachelor’s Degree in Life Science/Chemical/Biochemical/Electrical/Electronics/Control & Instrumentation and other engineering discipline
- Possess excellent understanding of 21 CFR Part 11, EMA and FDA (GxP) regulations, and GAMP methodologies
- Possess good understanding of Electrical and P&ID drawings
- Good knowledge in commissioning and validation of DCS (DeltaV), SCADA (WinCC, FactoryTalk View, Wonderware) & PLC (Siemens, Rockwell Automation) Systems
- Excellent written and verbal communication skills (including technical writing and presentations)
- Possess leadership skills and be able to take initiative to lead projects/discussions, involving multiple stakeholders, departments, and varying complexity
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