CSV Expert

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!

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)

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Join our Team!

Why you should work with us

Contact us
[email protected]