CSV Engineer

3 weeks ago

Cork, Cork, Ireland Tandem Project Management Ltd. Full time

Summary:

Our client, a pharmaceutical manufacturing company in Co. Kerry, is seeking a CSV Engineer to support site-based validation activities across multiple platforms. The successful candidate will be responsible for ensuring compliance with regulatory and internal requirements, collaborating closely with Automation, Quality, and IT teams. This role will involve validation of critical GMP systems including MES, BMS, PCS, and various digital platforms.

Responsibilities:

  • Authoring, reviewing and executing Computer System Validation (CSV) protocols and reports in alignment with GAMP 5 and applicable regulations.
  • Supporting validation activities for site systems including Siemens MES, BMS, PCS, TrackWise, and CMX.
  • Leading validation planning and risk assessments for new systems and upgrades.
  • Coordinating with cross-functional teams to ensure validation deliverables are completed within project timelines.
  • Supporting validation efforts for digital solutions including E-Logbook, Veeva Vault and other GMP data management platforms.
  • Maintaining and updating validation documentation to ensure audit readiness.
  • Providing support for CSV activities during regulatory inspections and internal audits.
  • Ensuring change control processes are appropriately followed for validated systems.
  • Engaging with vendors and system owners to ensure validation documentation and activities meet internal standards.

Qualifications & Experience:

  • Bachelor's degree in Engineering, Computer Science, or a related discipline.
  • Minimum 3 years' experience in a Computer System Validation or QA Validation role within the pharmaceutical or biopharmaceutical industry.
  • Proven experience supporting validation of systems such as MES, PCS, BMS, TrackWise, CMX and GxP applications.
  • Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity principles.
  • Experience with electronic document management systems such as Veeva Vault is desirable.
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