Job is active
Computer System Validation Engineer (Senior)
7 000 – 9 000 $
INTEGRIX SOLUTIONS PTE. LTD.Singapore
About this job
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
Market insight
41% above median5 661 $
5 661 $5 661 $
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