Process Engineer

Highly Competitive
  1. Permanent
  2. Field
  3. Belgium
Brussels, Belgium
Posting date: 20 Nov 2020
34272

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.

Job Responsibilities

  • 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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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