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
We are a process automation service provider for the life science industry. We provide automation solutions and manpower resources for day-to-day operations and projects.