jobs in INTEGRIX SOLUTIONS PTE. LTD.

INTEGRIX SOLUTIONS PTE. LTD. Hiring! Full Time Computer System Validation Engineer (Senior) in Islandwide (Singapore), Earn up to SGD 7,000 - Ricebowl

Computer System Validation Engineer (Senior)

INTEGRIX SOLUTIONS PTE. LTD.

Islandwide (Singapore)

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Working Location

  • Islandwide (Singapore) Singapore

Job Description

Responsibilities

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


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