Upstream process engineer
An exciting opportunity has arisen for an Upstream Process Engineer in Europe. In this role identify and develop purposely partnerships with key scientific influences to drive sources of patient value.
- Contributing to the transfer of purification processes from small-scale development units to the Pilot Plant and from Pilot Plant to the commercial manufacturing sites.
- Building and maintaining an effective network across Manufacturing sciences / Biologics Pilot Plant, Process Development, support teams, Quality Assurance, Analytical, suppliers and Global Regulatory Sciences groups.
- Providing technical expertise for the investigations and resolution of downstream process deviations in large scale cell culture processes through effective root cause analysis, Impact assessment, CAPA definition (& execution) and design of (pilot / scale down) studies. The role includes authoring change controls for new process introduction or to assess technical modifications.
- Design & troubleshooting, de-risking activities faced during the execution / introduction of the process in compliance with cGMP rules.
- Driving / supporting continuous improvements of equipment, systems and methods to increase Biologics Pilot Plant efficiency.
- Initiating design of new - or modified process equipment and supporting (re-) qualification of equipment, (re-) validation.
- Understanding and writing downstream process automation recipes (e.g. Unicorn).
- Providing subject matter expertise, representing the Downstream function at the Biologics Pilot Plant, during regulatory inspections and queries from health authorities.
- Demonstrating a strong knowledge of cGMP compliance
Skills and Requirements
- PhD, MSc or BSc level of education in process or bioprocess engineering or biotechnology related fields with at least 5 years of experience in downstream process development or manufacturing sciences in the biopharmaceutical industry.
- Strong knowledge of technologies and unit operations involved in downstream bioprocessing working with biologics.
- Practical experience with technology transfers, scale-up and optimization of processes.
- Track record of defining / leading / coordinating specific projects.
- Continuous improvement mindset and experience with lean manufacturing methodologies.
- Experience of equipment qualification / validation, including URS creation and qualification execution.
- Excellent oral & writing skills, both in French & English, to author and approve comprehensive and accurate technology and manufacturing documentation, procedures, specifications and protocols / reports.
- Ability to compile, analyze and summarize large amounts of information and complex situations into a comprehensive but concise document that efficiently supports decision making processes.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.