Computer System Validation Engineer (Senior)

Job Description: • Create, review or approve validation deliverables for GMP computerized systems including but not limited to: - User Requirements Specifications - Design Reviews - Criticality assessments - Validation protocols (IQ, OQ, PQ) - Incident/deviation reports related to test protocol execution • Provide validation guidance to cross-functional teams based on customers' Standard Operating Procedures (SOPs) • Provide QA oversight and review during different phases of the automation & ITOT projects in the pharmaceutical manufacturing industry • Validation of Process Control Systems and PLC system Requirements: • Degree in Engineering or Science, preferably in Chemical/Biochemical Engineering, Electrical Engineering or Computer Science/IT. • Minimum 3 years of computer system validation or automation experience in Pharmaceutical manufacturing Industry • Customer-focused and uphold high work quality standards • Excellent communication skills - ability to communicate and collaborate effectively with various stakeholders • Previous Emerson DeltaV, ITOT infrastructure, PLC experience is preferred • Experienced in developing and reviewing automation validation deliverables • Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines