USP Production Operator

For our Technical Operations Department we are looking for an USP Production Operator. On this position you will participate in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in manufacturing of biotechnology products in accordance with GMP principles and FDA requirements.

• Responsibility for the specification and purchase, qualification of production equipment,
• Participation in technology transfer in accordance with cGMP regulations and internal during the implementation of projects related to the introduction of new biotechnology products,
• Manufacture of biotechnology products in accordance with GMP principles and FDA requirements to obtain a product of specified quality in the specification,
• Writing of SOPs and manuals ( including manuals to equipment),
• Keeping documentation in accordance with the requirements of GMP,
• Attending and recording of process validation, writing/carrying out validation activities(OQ/PQ)

• Higher education (at least Msc) in Biotechnology, Pharmacy or similar,
• At least three year experience in biotechnological or pharmaceutical industry
• Good knowledge of cGMP and FDA requirements,
• Experience in process documentation and project documentation according to GMP requirements,
• Excellent knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage,
• Experience with mammalian cell culture. Additional advantage will be performing cultivation in production scale according to GMP rules.
• Very good speaking and writing English skills,
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required,
• Knowledge of Word for Windows and MS Office.