Technical Operations Specialist
We are seeking a skilled Technical Operations Specialist to join our team. This exciting opportunity offers the chance to work with an award-winning Pharmaceutical organization based in Cork.
The successful candidate will be responsible for providing process technical support to the Vaccines IPT team and other site departments which require Vaccine Process knowledge support. They will also report to the Vaccines IPT Associate Director.
Key Responsibilities:
* Support department and site level activities that require process and operational knowledge.
* Support process operations including trouble shooting technical and process related issues and leading investigations utilising MPS principles i.e. DMAIC/A3/OPPS etc.
* Managing EHS and Quality investigations, coaching, completing and overseeing batch record reviews.
* Lead cross-functional Technical Projects to further develop the Vaccine Process.
* Support and management of Process Robustness changes and product introduction.
* Lead cross-functional Projects problem-solving teams for troubleshooting and investigations within Vaccines IPT and across the site as required.
* Vaxneuvance POC for site compliance initiatives.
* Be responsible for providing a high level of 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.
* Adherence to highest standards for Compliance (Safety, Quality and Cost)
* Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
Required Skills and Qualifications:
* Degree or Masters in a Science or Engineering discipline (Preferably Biotechnology).
* 4+ years' experience in biopharmaceutical/vaccines environment
* Knowledge in material management and associated systems. Direct experience with Single Use Technology i.e. operational use, problem solving, vendor engagement.
* Direct experience in manufacturing with a problem-solving mindset. (Preferably Vaccine Drug Substance)
* Strong technical and process knowledge with background and experience in drug substance processing unit operations including UF/DF, Lyophilisation, Bottle filling, PAT, Single use technology deployment
About This Opportunity:
This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. We offer a competitive package and opportunities for career growth and development.