Computerized Systems Validation Expert
Gdańsk
Boost your career with us
Polpharma Biologics 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 medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities:
- 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)