Proclinical has partnered with a Biologics Pilot Plant in Brussels in search for a Process Engineer. This is a multiproduct facility, manufacturing biological Drug Substance for human use. As a Process Engineer, you will identify and foster purposeful partnerships with key scientific influencers to drive new 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.
- esign & 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 UCB's 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.