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
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062