Computer System Validation Engineer (Senior)

INTEGRIX SOLUTIONS PTE. LTD.

Date: 1 day ago

City: Singapore, Singapore

Salary: SGD 7,000 - SGD 9,000 / mo

Contract type: Contractor

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

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

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