Senior Process Engineer
4 weeks ago
Purpose
An exciting opportunity has arisen for a MS&T Senior Bioprocess Engineer. This position will be part of the MS&T team at our state of the art single-use multi-product commercialisation biotech site.
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.
Qualifications
- Minimum of 6 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.
- 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.
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