Vor 9 Tagen veröffentlicht

Process Validation Specialist (f/m/d) (80-100%)

Process Validation Specialist (f/m/d) (80-100%)

Process Validation Specialist (f/m/d) (80-100%)

Process Validation Specialist (f/m/d) (80-100%)

Lonza AG

Bio- und Nanotechnologie

Visp

  • Art der Anstellung: Vollzeit
  • 85.500 CHF – 103.000 CHF (von XING geschätzt)
  • Vor Ort

Process Validation Specialist (f/m/d) (80-100%)

Über diesen Job

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for a for MSAT Process Validation Specialist (80-100%). In this role, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs). Apply now and join this outstanding team!

Key responsibilities:

  • Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory mentorship.

  • Supporting R&D teams during the process characterization phase.

  • Reviewing and approving of process characterization documents.

  • Responsibility for the validation assessment on changes and deviations (approval of deviation and changes).

  • Preparation and maintenance of a detailed continued process verification plan.

  • Assessing and approving of Product Quality Reviews.

Key requirements:

  • Master in Chemistry, Biology, Biotechnology, chemical engineering or equivalent.

  • Experience in project management, preferable in Operations, MSAT, Quality and Compliance.

  • Experience in interaction with different collaborators within an organization and with regulatory agencies (Swiss medic, FDA etc.) would be an advantage.

  • First experience in mammalian is an advantage.

  • Ability to work on different tasks simultaneously and to work towards deadlines.

  • Proficient communication in English (written and spoken), additional proficient communication in German is appreciated.

On top of being an equal opportunity employer and value diversity at our company, we offer great benefits and a comprehensive relocation package for eligible talents! Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves.

At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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Unternehmens-Details

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Lonza AG

Bio- und Nanotechnologie

Köln, Deutschland

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