CLS Services

Gepubliceerd: 26 dagen geleden

Process Engineer

Leiden
Gepubliceerd: 26 dagen geleden
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention, we are searching for a Process Engineer.

Company profile
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Department
The ‘Down Stream Processing’ (DSP) department forms part of the Drug Substance Development group and develops & characterises processes for purifying and formulating recombinant viruses from harvest as a vaccine production platform. These processes must be safe, scalable and economically viable. They will be implemented in a GMP pilot plant facility for the production of clinical trial material and scaled-up for commercial production.

Job description
Process development consists of a USP and a DSP department and is responsible for the development of scalable, pharmaceutical-grade production processes for viral vaccines using mammalian cell lines as a production platform. Novel technologies are used to make sure that the processes are safe, reliable, scalable and cost-effective, so that the vaccines can be produced in large quantities at low costs. The developed production processes are transferred into GMP production facilities for the production of clinical batches and scaled-up for commercial production. All activities are performed in close collaboration with other departments.

We are looking for a motivated Process Engineer who can ensure a smooth tech transfer of new products in production (either the CTM pilot plant or production). The tech transfer includes both designing the required study plans, reviewing documentation from production, support during start-up and reporting afterwards. Subsequently you give 2nd line support of running production. Finally, you identify possible improvements for increased robust manufacturing and translate this back to development studies. As we are transferring our process to several sites over the world, we are looking for someone who is willing to travel and can give onsite support during the start-up of the plant.

Who we're looking for
The ideal candidate has a Ph.D. in a relevant discipline in biopharmaceutical sciences/engineering, biotechnology or chemistry or a PDEng with at least 3 years of hand-on experience in industry. You have experience with Tech Transfers and you have experience with scaling-up/scaling-down of processes, ideally with hands-on experience with DSP unit operations like IEX chromatography and UF/DF. Both experience with vaccine development and knowledge of GMP are advantages.
Requirements:

  • Experience with scale-up/scale-down of DSP processes;
  • Good communication skills;
  • Experience with cGMP requirements.;
  • Preferably experience with Lean/Process Excellence.


The most important competencies for this position are:
  • Enthusiasm to support production by hands-on presence during production (sometimes travelling required);
  • Pragmatic;
  • Demonstrated communication capabilities and the ability to bridge between production and development;
  • Data-analysis & report writing;
  • Quality, efficiency, accuracy and reliability of work;
  • Independent.


Additional vacancy information
Reference: A2000138
Contract: Temporary contract with CLS Services
Education: PhD.
Terms: Project for at least 1 year.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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