An exciting opportunity has arisen for a MS&T Senior Validation Engineer. This position will be part of the MS&T Hub at our new State of the Art single use Multiproduct Biotech facility at Dunboyne Biologics.
Key responsibilities will include:
- Participation in key technology transfers activities, in support of clinical and commercial new product introduction projects with a validation focus.
- Support development of strategies for and the execution of process and cleaning validation programs including protocol, report generation in a digital validation system and sample management.
- The MS&T Senior Validation Engineer will work across the site self-directed work teams and hub teams to identify and resolve issues to allow the site to deliver on our commit culture that support Quality, Environmental Health, and Safety (EHS), Learning and Continuous improvement.
- Acting as process Subject Matter Expert in the support of process investigations.
- Identification of innovation opportunities, support process optimisation projects including yield improvement or cycle time.
- Use of risk management techniques to assess strategies, prioritize activities and initiatives.
- The MS&T Senior Validation Engineer will be responsible for provision of technical expertise to ensure flawless launch and execution of new biologic-based medicines, the provision of technical leadership for product robustness in manufacturing, support of site investigations and risk management programs at the Dunboyne facility.
- The MS&T Senior Validation Engineer will be responsible for the technical coaching of others within the MS&T team to develop talent within the SDWT and MS&T Hub.
- The MS&T Senior Validation Engineer will act as the technical process lead on New Product Introduction projects and other selected projects within the MS&T Hub.
The successful applicant will have the following education, skills, and experience:
- Minimum of a Bachelor’s degree in a technical field (e.g. Engineering, Science or equivalent) with multiple experience in the biotechnology or pharmaceutical industry.
- Technical understanding of biological drug substance upstream and/or downstream purification unit operations.
- Experience in clinical or commercial technology transfer activities 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.
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.
