Technical Operations Specialist
About the Role
We are seeking a highly skilled Technical Operations Specialist to join our team at an award-winning Pharmaceutical organization based in Cork.
This is an excellent opportunity for anyone looking to work with a leading multinational company that is renowned for its excellence.
The Technical Operations Specialist will provide process technical support to the Vaccines IPT team and other site departments requiring Vaccine Process knowledge assistance.
The role reports directly to the Vaccines IPT Associate Director.
Duties and Responsibilities
* Support department and site-level activities requiring process and operational knowledge.
* Provide process operations support, including troubleshooting technical and process-related issues, and leading investigations utilizing MPS principles (DMAIC/A3/OPPS).
* Manage EHS and Quality investigations, coaching, completing, and overseeing batch record reviews.
* Lead cross-functional technical projects to further develop the Vaccine Process.
* Support and manage Process Robustness changes and product introduction.
* Lead cross-functional project-solving teams for troubleshooting and investigations within Vaccines IPT and across the site as required.
* Be responsible for providing high-level process knowledge to supporting functions and projects.
* Support and lead material management and troubleshooting with a cost focus.
* Apply Lean Six Sigma and Lean methodologies.
* Represent the department on cross-functional project teams.
Requirements
* Degree or Master's in a Science or Engineering discipline (preferably Biotechnology).
* 4+ years of experience in a biopharmaceutical/vaccines environment.
* Knowledge in material management and associated systems.
* Direct experience with Single-Use Technology (operational use, problem solving, vendor engagement).
* Direct experience in manufacturing with a problem-solving mindset.
* Strong technical and process knowledge with background and experience in drug substance processing unit operations (UF/DF, Lyophilisation, Bottle filling, PAT, Single-use technology deployment).
What We Offer
An exciting opportunity to work with a leading multinational company in the pharmaceutical industry.
A challenging role with opportunities for professional growth and development.
A dynamic and collaborative work environment.