Qualification/Validation Engineer // Johnson & Johnson in Bern

veröffentlicht
Kontakt
Stephan Zoebeli, Randstad Inhouse Services J&J Zug
Jobtyp
Temporär
jetzt bewerben

job details

veröffentlicht
Ort
Bern
Sektor
Life Sciences
Jobtyp
Temporär
Referenznummer
127140-94
Kontakt
Stephan Zoebeli, Randstad Inhouse Services J&J Zug
Telefon
058 231 57 94
jetzt bewerben

Stellenbeschreibung

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines AG, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, products that combat major threats to the health of people worldwide.

Main Responsibilities:

  • In charge of validation/qualification activities for (new) biopharmaceutical processes in the early and late Stage development department in order to ensure that:- Validation/Qualification phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities- Qualification Master plans are up to date and established for all ongoing projects
  • Plan, Coordinate and execute all phases for validation/qualification of equipment and computer system validation including impact/risk assessment, DQ, IQ, OQ
  • Prepare, review and approve technical and GMP related documentation (URS, qualification documentation)
  • Supporting the commissioning activities for new equipment and supporting the user in issuing URS
  • Coordinate and execute FAT/SAT, commissioning activities in collaboration with internal and external partners
  • Coordination and oversight of external qualification partners
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to process equipment and cleaning

Qualifikation

Who we are looking for:

  • Bachelor/Master Degree in technical or natural sciences
  • 2+ years of work experience within a pharma or biotech company
  • Experience in the pharma/biotech Fill Finish environment is a plus
  • Basic Know-how of biotechnology processes
  • Knowledge of Validation/Qualification requirements according to cGMP
  • Know-how of quality assurance principles
  • Analytical thinking and problem-solving ability
  • Good verbal and written communication in German and English
  • Furthermore, we are looking for a team player, self-starter and a good time manager

This role based in Bern, Switzerland will initially be limited to approx. 9 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!