Bioprocess Engineer Position
2 weeks ago
We are currently seeking a highly skilled Bioprocess Engineer to join our team at Life Science Recruitment. The ideal candidate will have experience in a biologics drug substance environment and technical expertise in biological drug substance upstream and/or downstream purification unit operations.
The successful candidate will be responsible for participating in and leading key technology transfers activities, supporting clinical and commercial new product introduction projects. They will also develop strategies for and support the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
This is an excellent opportunity for a motivated and experienced professional to take on a challenging role and contribute to the success of our organization.
Key Responsibilities:
- Participate in and lead key technology transfers activities, in support of clinical and commercial new product introduction projects.
- Develop strategies for and support the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
- Act 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:
To be considered for this position, you will need to have:
- Experience 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.
If you are a motivated and experienced professional looking for a new challenge, please contact us for more information.
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