#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
For our Technical Operations Department we are looking for a Process Support Specialist. 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.
- Elaboration, verification design and qualification documentation. Participation during equipment and systems qualification.
- Elaboration of Batch Record, SOPs and manuals (including manuals to equipment).
- Participation and monitoring of technology transfer processes and commercial production in accordance with the principles of cGMP and internal regulations
- Supporting qualifying activities, supervision of qualification documentation in accordance with GMP and internal regulations
- Monitoring the progress of preparation for inspections / external and internal audits
- Running and monitoring the manufacturing process of biotechnology production according to GMP requirements, technological documentation and other internal requirements.
- Main areas of responsibility: Solution preparation systems (buffers and culture media), CIP and SIP installation, dispensing, material transfers, automated washing and sterilization processes.
- Problem solving, explanation of deviations, implementation of changes in accordance with GMP and internal regulations
- Higher education in Biotechnology, Pharmacy or similar
- At least 3 years’ experience in biotechnological or pharma industry
- Good knowledge of cGMP and FDA requirements
- Good knowledge of autoclaving, CIP/SIP, media and buffer preparation, materials handling processes in industrial scale
- Experience in keeping and reviewing manufacturing documentation (batch record, SOP's) and project documentation according to GMP
- Knowledge of USP and DSP process and working with recombinant proteins will be additional advantage requirements
- Knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage
- Fluent English
- Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com