Summary:
Our client is a multinational biopharmaceutical company based in Cork looking for a Tech Transfer Specialist to provide technical support for the technology transfer and scale-up of new processes for Vaccines manufacture meeting the Manufacturing priorities of Compliance, Supply, HPO, Strategy and Profit Plan.
Responsibilities: Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities. Responsible for the technical transfer and scale–up of a new process into Vaccines. Input into Technical planning and decisions for the Vaccines, to ensure supply of high-quality product through tactical planning and execution of production schedules. Technical Review, ownership of and approval of Change Control, Quality Notification, deviation and investigation records as required. Recommend technical approaches in line with global and local standards. Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances. Contribute for driving a culture of Continuous Improvement by deploying MPS within the vaccines on projects such as: problem solving, reducing cycle time, Lean principles within the new processes. Participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant. Responsible for supporting a culture of Continuous Improvement by championing problem solving tools within Technology Transfer for Vaccines. Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation. Qualifications & Experience: Hon degree or Masters in a Science or Engineering discipline (preferably Biotechnology). 4 years' experience in biopharmaceutical/vaccines environment. Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage. Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area. Preference for Lean Six Sigma qualification or experience of application of Lean principles. Project management qualification such as, Project Management Professional is desirable. Evidence of Continuous Professional Development. Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.). Demonstrated ability in holding project team members responsible for results and being decisive about non-performers. Advanced PC skills such as Excel, Word, PowerPoint. Experience in a FDA / HPRA Regulated production environment.
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