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 biotech facility at Dunboyne Biologics.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- 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.
- Support in the coaching and development of other members of the MS&T team.
- Responsible for the use of process engineering systems and approaches for equipment design, specification and performance, generation of technical reports, process modelling, risk management and integration of process equipment systems.
- 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.
- Work as part of a team of engineers who will be responsible for ownership and management of change of the electronic batch records, identifying equipment, recipe and process improvements and managing and controlling changes in these areas.
What skills you will need
- 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.
- 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.
- Experiencewith automated systems (PAS, MES) highly desired
- Process validation and cleaning validation experience desired.
- Ability to manage multiple priorities and knowing when to escalate for resolution.
- Flexible and self-motivated, with proven ability working cross functionally delivering technical solutions to issues
- Ability to travel internationally as role will have a minimal travel requirement (approx. <5% p.a.).
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
