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