14 Mar [2018-03] Cell Processing Engineer – Filled
Cell Processing Engineer – Filled
CellProthera is a biotech company based in the BioValley, one of the leading life science clusters in Europe. It is developing innovative cell therapy products based on a proprietary cell processing technology platform. A multi-center Phase I/IIb clinical trial is currently on-going in Europe to treat patients having suffered from severe acute myocardial infarction.
Your mission
Under supervision of the Development and Industrialization Director, your role will focus on the development of our cell processing platform. Your main responsibilities will be
- Qualify and validate the automated cell processing system, including both equipment and consumables
- Manage the overall project in order to meet the deadlines, maintain the budget and propose/take corrective actions in case of deviations
- Together with R&D and Regulatory teams, prepare technical documentation, validate protocols, carry-out laboratory tests, write reports and qualify equipment
- Drive, negotiate and follow-up with industrial partners while developing and maintaining a long-term, trust relationship with them
- Verify accuracy and completeness of technical documentation
- Identify and analyze improvement area and propose design changes/optimizations, new technologies and suppliers
- Ensure and coordinate the maintenance of the installed base during clinical trial phase I/IIb
- Follow-up and apply in everyday work current industry standards and regulations
Your profile
- Engineer degree in mechanical engineering, mechatronics, process engineering or equivalent, preferably with bioengineering major
- A minimum of 3 years’ experience in the industry, preferably in the medical device or/and biotechnology industry
- Knowledge of Medical Device Directive, CE marking, ISO 13485, FDA regulations
- Self-driven with excellent communication, reporting and analytical skills and teamwork
- Rigorous, hard-working, result-oriented, troubleshooting and hands-on person
- English fluent. French conversational
Applicants should also be entitled to work within the European Economic Area (EEA) and willing to travel worldwide (10-25%)
Position in Mulhouse (Fr). If you are interested in this job, please contact Paula Lee (plee@cellprothera.com)