Job Description:
We are currently recruiting for an exciting opportunity with a leading multinational pharmaceutical organization based in Tipperary.
This is an excellent position for individuals who want to join a company that excels in its field and make a meaningful contribution to the development of innovative pharmaceutical products.
Duties:
* As an Operations Engineer, you will provide day-to-day engineering support to the B-Con OSD Operations Team in the B-Con OSD area, bringing energy, knowledge, and innovation to this role.
* You will be responsible for developing, reviewing, and approving all SOPs/SWIs for B-Con OSD Operations, ensuring compliance with industry standards and regulations.
* You will serve as the operations representative on Commissioning and Qualification of Continuous Manufacturing Module in B-Con OSD, working closely with cross-functional teams to ensure smooth project execution.
* You will also be part of the Containment Verification Team for B-Con OSD, aligning containment verification steps with operations procedures to ensure the highest level of quality and safety.
* In addition, you will develop training programs for B-Con OSD Operations by membership of the Potent Training Team, creating engaging and effective learning experiences for team members.
* You will complete all safety permitting approvals for High-Risk work in B-Con OSD during Operations start-up, ensuring a safe working environment for all employees.
* You will be responsible for developing HECPs for B-Con OSD equipment, maintaining accurate records and documentation throughout the process.
* You will also develop all safety risk assessments for B-Con OSD Operations, identifying potential hazards and implementing control measures to mitigate risks.
* You will be responsible for deploying fit-for-purpose MPS in B-Con OSD with foundational structures in place from start-up, ensuring efficient and effective operations.
* You will develop the B-Con OSD MPS roadmap and measure deployment versus target, continuously improving processes and outcomes.
* You will provide technical/operational expertise on continuous improvement projects, driving innovation and excellence within the organization.
* Finally, you will ensure GMP compliance through completion of factory walkdowns and activities required for B-Con OSD Licensing, maintaining the highest level of quality and regulatory compliance.
Education & Experience:
* A Third-Level qualification in Manufacturing, Engineering, or Science discipline OR relevant manufacturing formulation experience, preferably in potent formulation.
* A minimum of 5 years industrial experience, with a strong track record of delivering results and driving improvements.
* Lean Six Sigma Certification is an advantage, but not essential.
* SAP/MES knowledge/experience is highly desirable.
* Project Management skills are not essential, but a plus if you have them.