We are currently seeking an Operations Engineer to join our Pharmaceutical organization based in Tipperary.
This is an excellent opportunity for a talented professional who is looking to work with a leading multinational company that excels in its industry.
Duties:
* The Operations Engineer will report to the B-Con OSD Operations Lead and provide day-to-day engineering support to the B-Con OSD Operations Team in the B-Con OSD area.
* Develop, review and approve all Standard Operating Procedures (SOPs) and Site Work Instructions (SWIs) for B-Con OSD Operations.
* Act as the operations representative on the Commissioning and Qualification of Continuous Manufacturing Module in B-Con OSD.
* Represent the operations team on the Containment Verification Team for B-Con OSD, ensuring containment verification steps align with operations procedures.
* Develop training programs for B-Con OSD Operations by participating in the Potent Training Team.
* Complete all safety permitting approvals for High-Risk work in B-Con OSD during Operations start-up.
* Responsible for developing Hazard Evaluation and Control Plans (HECPs) for B-Con OSD equipment.
* Develop all safety risk assessments for B-Con OSD Operations.
* Responsible for deploying fit-for-purpose and stage-appropriate Manufacturing Process Systems (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 and operational expertise on continuous improvement projects.
* Maintain GMP compliance by completing factory walkdowns and activities required for B-Con OSD Licensing.
Education & Experience:
* 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 or experience.
* Project Management is not essential but beneficial.