Job Description:
Global Biotechnology company, based in south Dublin, Ireland – looking for Program Manager.
The successful candidate will lead and coordinate Operational Readiness execution for AVI inspection lines SI02 and SI03 through PQ, ensuring people, process, systems, documentation are prepared to support qualification and operational handover. The role ensures readiness activities are integrated with project execution and qualification plans while maintaining compliance, governance, and delivery discipline.
The Role:
* Own the Operational Readiness strategy and execution for AVI inspection lines SI02 and SI03 through qualification and PQ.
* Integrate readiness activities with capital project execution, commissioning, and validation milestones.
* Provide programme level oversight of readiness work-streams including documentation, training, change control, validation interfaces, MES readiness, and operational handover.
* Act as the primary Operational Readiness interface between Capital Projects and Operations for the AVI scope.
* Maintain integrated readiness plans, trackers, and dashboards aligned with the ADL1X master schedule.
* Identify readiness risks, gaps, and dependencies and drive mitigation through governance.
* Provide clear readiness input to programme and senior leadership governance forums.
* Ensure all Operational Readiness activities conform to cGMP requirements.
* Ensure scope and financial discipline in line with site governance.
* Support inspection readiness and regulatory interactions as required.
Have You:
* Technical degree or equivalent experience in Engineering, Science, or Operations.
* 8+ year's experience in Pharmaceutical, Biotechnology, or Life Sciences manufacturing.
* Experience supporting Operational Readiness, capital project delivery, or qualification activities.
* Experience operating within GMP regulated environments.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com
