Join a leading multinational pharmaceutical organization based in Tipperary, Ireland. This exciting opportunity is ideal for individuals seeking a challenging role with an award-winning company.
Duties
* The Operations Engineer reports to the B-Con OSD Operations Lead and provides day-to-day engineering support to the B-Con OSD Operations Team in the B-Con OSD area.
* Develop, review and approve Standard Operating Procedures (SOPs) and Software Instructions (SWIs) for B-Con OSD Operations.
* Represent operations on Commissioning and Qualification of Continuous Manufacturing Module in B-Con OSD.
* Participate in Containment Verification Team for B-Con OSD, ensuring containment verification steps align with operations procedures.
* Develop training programs for B-Con OSD Operations as a member of the Potent Training Team.
* Obtain safety permitting approvals for High-Risk work in B-Con OSD during Operations start-up.
* Develop Hazard Evaluation and Control Procedures (HECPs) for B-Con OSD equipment.
* Conduct safety risk assessments for B-Con OSD Operations.
* Deploy fit-for-purpose and stage-appropriate Maintenance, Planning, and Scheduling (MPS) in B-Con OSD with foundational structures in place from start-up.
* Develop the B-Con OSD MPS roadmap and measure deployment versus target.
* Provide technical/operational expertise on continuous improvement projects.
* Maintain GMP compliance through factory walkdowns and completion of activities required for B-Con OSD Licensing.
Requirements
* Hold a Third Level qualification in Manufacturing, Engineering or Science discipline, or relevant Manufacturing Formulation experience, preferably in potent formulation.
* Minimum 5 years industrial experience.
* Lean Six Sigma Certification is an advantage.
* SAP/MES knowledge/experience.
* Project Management is not essential.