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Validation Lead

Excellent opportunity for a Validation Lead to join a Global Biologics Company in the Northwest of Ireland. The Validation Lead will oversee cGMP equipment, systems, and process qualification/validation for routine operations. The Lead Validation expert will also manage the revalidation of critical systems and processes.

Overview of your responsibilities:

  • Lead, coach, and guide the Validations team

  • Provide technical oversight in key areas

  • Coordinate Revalidation Schedule on Maximo for timely completion

  • Assist Validation Manager in training, metrics, and audit preparation

  • Ensure compliance with global standards and regulatory requirements

  • Collaborate with other Team Leads for timely validation completion

  • Manage personnel for collective project delivery schedules

  • Provide project delivery timelines data for compliance and expenditure

  • Report team KPI data for validation, calibration, and revalidation

  • Attend Departmental, APEX, Safety Gembas, and Green Team Meetings

Knowledge, Skills, and Experience Required for the Role:

  • Bachelor’s degree in engineering or scientific discipline

  • 4+ years experience in cGMP regulated environment with successful validation activities

  • Advantageous to have people leadership experience

  • High attention to detail and mental concentration for accuracy and compliance

  • Expertise in relevant subject areas such as cleaning, CSV, Aseptics, process, CPV, Facility

For a confidential discussion and more information on the role contact Courtney Russell

+353 (0) 71 9108062