Your Role

• 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.
   

Your responsibilities

• Elaboration, verification design and qualification documentation. Participation during equipment and systems qualification;
• Elaboration of SOPs and manuals ( including manuals to equipment);
• Documentation preparation according GMP rules and internal company requirements;
• Attending during technology transfer, process validation in cooperation with Research and Development Department // Client;
• Running and monitoring the manufacturing process of biotechnology product  according to GMP requirements, technological documentation and other internal requirements;
• Supporting of production team in aim of effective resources utilization, conducting the trainings;
• Actual delivering supervisor or  proper people reports and all necessary documentation to process evaluation;
• Informing direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions;. 
• Worthy of representing the company;
• Report preparation of performed tasks;
• Work organizing and impact on the work of others in order to make the most effective use of working time and performance of tasks;
• Keeping documentation in accordance with the requirements of GMP;
• Preparation and updating of system documents, procedures and instructions as well as related documentation in accordance with the GMP requirements; 
• Running the training for employees of the Production Department;
• Close cooperation with the Quality Department;
• Participating in audits of suppliers of services and materials related to the production;
• Cooperation with  all Production Department team and other groups from site and Polpharma Biologics; 
• Participation in investigation for quality deviations and implementation of CAPA;
• Conducting and participating in trainings;
• Working on shifts.

If you have

• Very good speaking and writing Polish (level C1);
• Higher education (at least Msc) in Biotechnology, Pharmacy or similar;
• Experience in qualification of production equipment;
• At least one year experience in biotechnological or pharmaceutical industry;
• Openness to work on shifts;
• Experience in work with recombinant proteins and their purification. Performing monoclonal antibody purification process in production scale according to GMP rules;
• Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required;
• Very good speaking and writing English skills (level B2);

 We offer

• Competitive salary;
•  Private healthcare;
•  Life insurance;
• Pension plan above national standards;
•  Relocation package;
• Additional free day;
•  and more...