System Validation Expert

3 days ago


Singapore beBeeComputer Full time $80,000 - $120,000

Job Title: Computer Systems Validation Specialist


Job Description:

The systems validation specialist will collaborate with a team of engineers to develop a comprehensive validation strategy and protocols for computerized systems.

  • Develop validation strategies, plans, reports, risk assessments, and requirement traceability matrices for new or changed validation systems.
  • Coordinate validation activities at the site level, collaborating with cross-functional groups.
  • Assist in updating automation system life cycle documentation, SOPs, risk assessments, and requirement traceability matrices.
  • Review and approve validation protocols, reports, and deliverables for specialized validation areas.
  • Define requirements for validation activities and ensure regulatory compliance based on risk assessments.
  • Creation and/or review of lifecycle documents: user requirement specifications, functional specifications, risk assessments, validation protocols (IQ/OQ/PQ/CPV), and reports.

Requirements:

  • Degree in Engineering, Pharmaceutical Science, or related studies is required.
  • At least three years of experience in a CSV role within the pharmaceutical industry is essential.
  • Good fundamental technical knowledge of automation systems, such as Siemens PCS7 or DeltaV, is necessary to assist engineers in developing life cycle documentation.
  • Knowledge of GAMP5, ANSI/ISA-88, and 21 CFR Part 11 requirements is essential.


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