CLS Services

Gepubliceerd: 25 days ago

Process engineer equipment COVID

Leiden
Gepubliceerd: 25 days ago
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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 equipment COVID.

Company profile
Janssen Vaccines & Prevention B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson and is passionate about the development, production, and marketing of vaccines to prevent and combat infectious diseases. The Drug Substance Operations (DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden where we proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV, and Ebola. This is also the place where we will be producing the COVID-19 vaccine material.

Department
The DSO department is an international team of about 40 people working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to support the development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA, and warehouse. Their passion is to deliver high-quality results to their customers and to seek opportunities for improvement: never a dull moment!
Within the department four teams operate, each with specific responsibilities: Preparations, Cell culture, Downstream processing, and the Operations Support Team. The teams are responsible for their cGMP status by regular equipment care, maintaining the documentation system, reporting quality issues, and performing the resulting corrective actions, training, and inspection readiness.

Job description
Are you able to strengthen the Operations Support Team within DSO to realise the upcoming COVID-19 vaccine manufacturing campaign?
As Process Engineer equipment, you are the first point of contact with Engineering, Validation, and Maintenance (EVM) to introduce new equipment and maintain the existing equipment. Together with the development teams and EVM, processes (in sync with cGMP regulations) are introduced in the pilot facility including documentation and training. The ultimate task is to assure equipment is available at all times to allow smooth operation activities.
Responsibilities:

  • Be the first departmental contact for questions about equipment;
  • Lead to assure the availability of compliant equipment and processes in the department support troubleshooting and investigation in non-conformances (process and equipment related);
  • Lead and support process excellence activities to continuously improve the work. Initiate and handle equipment related compliance records (change controls, non-conformances and CAPA records);
  • Work precisely and detect opportunities for improvement with proper follow up, both on work processes as well as personal development.


Who we're looking for
We are looking for a candidate with at least a B.Sc. and a minimum of 4 years’ experience in the pharmaceutical industry/biotechnology (cell culture equipment, downstream process equipment, etc.). Experience with cGMP and EHSS standards is required. You have a proven track record with handling change controls, deviations, etc.
Project management experience is a plus and you are able to maintain oversight in a hectic environment as well as to pull relevant departments together. You have good understanding of Quality Assurance of regulatory requirements and industry guidelines specific for the pharmaceutical industry and maintenance and engineering (e.g. GMP, NEN 3140, VCA, CE).
Lean green belt certification is preferred.


Additional vacancy information
Reference: A2000053
Contract: Projectmatig dienstverband met CLS Services
Education: HBO/BSc.
WO/MSc.
Terms: Project for 1 year. In principle this is temporary additional resource requirement due to excess work, not anticipating extension at present. This would normally be a full-time on-site role.
Full time preferred, 32 hours discussable.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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