#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!
WE ARE LOOKING FOR:
CSV Expert
Gdańsk Science & Technology Park, Trzy Lipy 3
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
You will take care of:
- Shape CSV processes in Polpharma Biologics Gdansk and cooperate within global organization for processes harmonization
- Prepare, review and consult Validation Documentation through entire systems lifecycle in Polpharma Biologics
- Drive initial Validation approach and key activities for projects in Digitalization program
- Support GxP Automation & IT systems’ design and modifications within investment projects; plan & execute appropriate actions to keep GxP compliance in control
- Quickly develop your skills and gain experience thanks to the following:
- Work hand in hand and on a daily basis with Automation Engineers
- Prepare company for inspections and audits within CSV area
- Review, compare & align CSV approach within different projects in Technical Operations, Engineering, QC, R&D and IT
If you have:
- Higher education related to automation, robotics, information or similar studies
- Knowledge of cGMP and FDA requirements
- Experience in validation documents creation and leading CSV projects
- Ability to diagnose and solve problems, good work organization skills, efficient work under pressure
- English advanced/fluent.
- Experience in designing and managing computerized systems in regulated environment
- Experience in automation and IT projects management
Join our Team!
We offer
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com