Manufacturing Specialist Operations Support
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 a Manufacturing Specialist Operations Support.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
As manufacturing specialist, you will support the production batches in the Vaccine Launch Facility (VLF). You are the lead in solving acute problems, detecting abnormalities and implementation preventive actions. In parallel with these process and manufacturing activities, you are responsible as equipment owner for the corresponding production equipment, documentation and training. As manufacturing specialist, you work closely with your operations support team and within the other teams of the VLF.
You will be responsible for:
- Taking part in activities related to the production support of cGMP batches in the launch facility. This includes processes such as waste disposal, storage of product in the freezer park, shipments, single use supply, fumigation of the VLF, sampling etcetera;
- Acute troubleshooting when problems occurred during production;
- Taking the lead in root cause investigations of complex deviations and for the implementation of preventive actions;
- The production documentation of the process equipment and batch records to ensure successful production runs can be produced;
- As equipment owner, that the production equipment is in validated state and well maintained, and that there is enough capacity for production to meet the production schedule;
- As equipment owner, the process equipment related reports and KPI’s. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity);
- Initiating and handling of compliance records (Change controls, events, CPA, deviations, reports);
- Leading process excellence activities to continuously improve the work as well as personal skills.
Who we're looking for
B.Sc. or M.Sc. with experience in production support of biologicals/vaccines in a cGMP environment. As equipment owner, you have experience with corresponding production equipment, documentation and training. Do you have experience handling compliance records and do you have good interpersonal skills? Then this is a great opportunity for you!
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