Computer System Validation Engineer (Senior)
Meħtieġ:QA/Test
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