Computer Systems Validation Professional

3 days ago


Singapore beBeevalidation Full time $100,000 - $120,000

We are seeking a professional to fill the role of Computer Systems Validator.

Job Description

The ideal candidate will have experience in developing and implementing computer validation strategies, plans, protocols, and reports for new or changed validation systems. Additionally, they should have a strong understanding of automation systems such as Siemens PCS7 and DeltaV, as well as knowledge of GAMP5, ANSI/ISA-88, and 21 CFR Part 11 requirements.

Key Responsibilities
  • Develop and implement computer validation strategies, plans, protocols, and reports for new or changed validation systems.
  • Schedule and coordinate validation activities with cross-functional groups.
  • Assist in raising change control to update automation system lifecycle documentation, SOPs, risk assessment, and requirement traceability matrix.
  • Review and approve validation protocols, reports, and deliverables for specialized validation areas.
  • Define requirements for validation activities and ensure regulatory compliance based on risk assessment.
  • Creation and/or review of validation lifecycle documents, including user requirement specification, functional specification, risk assessments, validation protocols, and reports.
  • Review and check documentation for GMP compliance.
  • Collaboration and/or creation of validation summaries.
Required Skills and Qualifications
  • Degree in Engineering, Pharmaceutical, or Computer Science or related studies.
  • At least 3 years of experience in a CSV role within the pharmaceutical industry.
  • Good fundamental technical knowledge of automation systems, such as Siemens PCS7 and DeltaV, to assist automation engineers in developing life cycle documentation.
  • Knowledgeable in GAMP5, ANSI/ISA-88, and 21 CFR Part 11 requirements.


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