Lead, Computer System Validation

Mallinckrodt Pharmaceuticals

College Park, Dublin
Not specified (assumed to be hybrid or on-site based on the nature of the role).
Gxp computerised systems experience
Risk-based csv/csa approach
Validation planning for new implementations
Mallinckrodt Pharmaceuticals is seeking a Lead for Computer System Validation in Dublin, responsible for overseeing the implementation and governance of GxP computerized systems across their internal manufacturing sites. The ideal candidate will have significant experience in validation within the pharmaceutical sector, strong leadership abilities, and a comprehensive understanding of relevant regulations

Job Summary

  • The CSV Lead is responsible for leading the implementation and lifecycle management of GxP computerised systems across internal manufacturing sites.
  • This role ensures that all activities are aligned with current Engineering and Quality standards, supporting inspection readiness and data integrity.
  • The position involves coaching site teams and driving continuous improvement initiatives to enhance compliance and efficiency.

Matching Summary

Match Score: 85

Mallinckrodt Pharmaceuticals is seeking a Lead for Computer System Validation in Dublin, responsible for overseeing the implementation and governance of GxP computerized systems across their internal manufacturing sites. The ideal candidate will have significant experience in validation within the pharmaceutical sector, strong leadership abilities, and a comprehensive understanding of relevant regulations.

Skills & Requirements

Must-have

  • GxP computerised systems experience
  • risk-based CSV/CSA approach
  • validation planning for new implementations

Nice-to-have

  • strong stakeholder management skills
  • continuous improvement orientation
  • excellent technical writing skills

Key Requirements

  • Master’s degree in engineering or related field
  • 5–10+ years of experience in CSV
  • experience supporting regulatory inspections

Work Rights

Not specified

Tailored Resume

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