Senior USP Specialist

For our USP Specialist Department we are looking for a Senior USP Specialist. In this position you will actively participate in the 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 the manufacturing of biotechnology products in accordance with cGMP principles and will do this in accordance with European and FDA requirements. 

• Writing of verification design and qualification documentation. Participation during equipment and systems qualification.
• Writing of SOPs and manuals (including manuals to equipment). Documentation preparation according cGMP rules and internal company requirements.
• Participation in technology transfer and process validation in cooperation with MSAT and external Clients.
• Monitoring the manufacturing process of biotechnology production according to cGMP requirements, technological documentation and other internal requirements.
• Coordination of production team in the aim of effective resources utilization, conducting the training where necessary                                
• Close cooperation with the MSAT, Production Operational Department and Quality Department, and of system documentation in the Production Department
• Participattion in the preparation for inspections and audits (external and internal)      as and where required            

• Higher education in Biotechnology or at least 5 years of experience in biotechnological or pharmaceutical industry
• Excellent knowledge of cGMP, EMEA and FDA requirements
• Experience with mammalian cell culture. Additional advantage will be performing cultivation in production scale.
• Experience in keeping and reviewing process and project documentation according to cGMP requirements
• Excellent knowledge of aseptic techniques and Upstream Processing, Single Use Technology used in biopharmaceutical production will be additional advantage
• Experience in work with recombinant proteins will be additional advantage
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks
• Fluent English would be an advantage