Associate GMP Specialist VLF
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 Biologics B.V., we are searching for an Associate GMP Specialist VLF.
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, talented and multi-scaled people are working in a dynamic culture in which innovation and a #39;can do#39; state of mind are the central points.
The Vaccine Launch Facility (VLF) is a state-of-the-art vaccines GMP manufacturing facility located at the Bioscience park in Leiden, where they produce vaccines against infectious diseases, such as HIV RSV. The VLF is designed to manufacture drug substance on a 1000 L scale for Phase III and commercial purposes. As a response to the global COVID-19 pandemic, the VLF has been appointed as one of the production sites for Janssen’s lead vaccine candidate for COVID-19.
The Centre of Expertise (CoE) plays a central role within the VLF, divided in three expertise: 1) GMP specialism, 2) Single use technology and 3) Manufacturing systems specialism. The CoE is responsible for batch continuation by troubleshoot & support in production, robust and availability of process equipment, and control and change management of GMP processes. The CoE is key in clear translation of strategic and tactic projects to a workable process and environment for the shop floor. They always work against the high-quality standards and safety and compliance regulations that are applicable for vaccine manufacturing.
The CoE is part of the Operations Department which holds around 60 people and is divided in 4 teams. 3 Teams are responsible for the actual on time production and delivery of the batches (USP, DSP and Operations Support) and 1 Team (COE) is responsible to support the production teams with specialised and in-depth knowledge and skills on our production processes. The Centre of Expertise (COE) is a team of around 15 people.
Would you like to be directly involved in the fight against the global COVID-19 pandemic and do you have experience within QA and EHSS? Then keep reading!
As Associate GMP Specialist, you will support the operations teams in general cGMP and EHS related tasks (changes, quality issues, training, GMP and EHS documentation and reports). Thus, you also support a safe, healthy and sustainable work environment.
In different team settings, you will work on maintenance and improvement of the general VLF GMP procedures and GMP systems to ensure successful production runs can be produced. Furthermore, you will (pro) actively assist in safety related issues and improvements.
As Associate GMP Specialist, you work closely with your Center of Expertise colleague’s and the VLF staff engineers and with all the other teams of the VLF. As well as GMP Training, Document control department, QA department, and Compliance department.
You will be responsible for:
- Support in keeping general VLF GMP documentation up-to-date;
- Support in improvements on production processes and systems within the VLF;
- Support in improvements regarding relevant EHSS standards applicable to the VLF (including support in ongoing EHSS investigations);
- Writing change controls for the GMP/ EHS systems and VLF improvements, and responsible for follow up and timely documentation and completion;
- Support lead deviation investigation in documenting product impact analysis and root cause investigation and timely follow up (including CPA records) and completion;
- Training co-ordinator and responsible for the training-syllabi within the VLF;
- Co-ordinator of documentation periodic review within the VLF;
- Co-ordinator internal batch release (WVS, IVP, DS);
- Working precisely, detecting and solving acute problems and communicate possible abnormalities;
- Leading process excellence activities to continuously improve the work as well as personal skills.
Who we're looking for
The ideal candidate has a B.Sc. or M.Sc. in biotechnology, biochemistry, biomedicine, process technology with 2-4 years of experience in a biotechnology or biopharmaceutical industry environment. You have experience with cGMP and EHSS standards and general knowledge of cell culture (USP), bioreactors, virus propagation and/or downstream processing (DSP). Experience with Trackwise QEM, Docspace and/or CURVE is advantageous.
We are looking for someone with good communication skills in both Dutch and English, with a high degree of accuracy, initiative, and independence. Are you the enthusiastic, stress-resistant team player we are looking for?
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 1 year.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555