An exciting opportunity has arisen for a Bioprocess Engineer. This position will be part of the MS&T team at our client's biotech facility in co Meath.
Job Summary:
The Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion. Participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions. Identify, analyze and prioritize technical or business related processes improvement-opportunities and problems. Initiate and coordinate improvements for technical or business processes, systems and behaviors. Contribute to a data driven decision making process, Ensure effective application of LeanSixSigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners.
Responsibilities:
* Responsible for the participation in and leading of key technology transfers activities, in support of clinical and commercial new product introduction projects.
* Development of strategies for and support in the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
* Acting as process Subject Matter Expert in the support of process investigations.
* 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.
* Acting as system owner and Subject Matter Expert (SME) to support investigations and using risk management techniques to prioritize activities and initiatives.
* Ongoing optimization of process equipment and development of future breakthrough business solutions.
Requirements:
* Bachelor’s Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with experience in the biotechnology or pharmaceutical industry.
* Minimum of 5 years in a biologics drug substance environment.
* Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
* Experience in technology transfers for clinical or commercial biologics strongly desired.
* Experience with automated systems highly desired
* Process validation and cleaning validation experience desired.
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