Ref. 01255
Senior Bioprocess Engineer – MS&T
An exciting opportunity has arisen with our client, a leading Pharmaceutical company based just outside Dublin, in Dunboyne, Co. Meath. We are seeking a MS&T (Manufacturing, Science, and Technologies) Senior Bioprocess Engineer. This position will be part of the MS&T team at a state of the art single-use multi-product commercialisation biotech facility.
In this role, you will be responsible for introducing new processes and/or products (product transfer), developing and transferring knowledge of Lean Six Sigma, Change Management and Inclusion. You will also initiate and coordinate improvements for technical or business processes, behaviors and systems.
Responsibilities
• Responsible for the participation in and leading of main technology transfers activities, in support of clinical and commercial new product introduction projects.
• Act as a process Subject Matter Expert in the support of process investigations while using risk management techniques to prioritize activities and initiatives.
• Development of strategies to support in the execution of technology transfer, process and clean validation programs in line with regulatory standards.
• Use of risk management techniques to assess strategies, prioritize activities and initiatives.
• Lead other significant business critical projects on site associated with new product introduction and site capability build.
• Ensure the continuous optimization of process equipment and development of future breakthrough business solutions.
• Ensure effective application of Lean Six Sigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners.
Requirements
• Minimum of a Bachelor’s Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with experience in the biotechnology or pharmaceutical industry.
• 6 years+ of experience in a Biologics drug substance environment
• Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
• Minimal work direction needed, highly skilled and knowledgeable to the position.
Desirable
• Experience in technology transfers for clinical or commercial biologics.
• Process validation and cleaning validation experience.
• Experience with automated systems.
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