Commissioning Qualification Validation Engineer (f/m/x)

Lysalto AG
Vaud

3T

ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.

With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.

We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.

Learn more about us on our webpage : www.altogen.ch

Commissioning Qualification Validation Engineer (f/m/x)

ALTOGEN is a swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.

With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.

We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.

Learn more about us on our webpage : www.altogen.ch

As a Commissioning Qualification Validation Engineer you will provide our clients with the necessary expertise and assistance to further improve and maintain the quality standards for their operations and products.

This project take place in a Greenfield project. The scope of this activity include : HVAC, Clean room, Cold room and infrastructure. Any experience on clean and black utilities could be a plus.

  • Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
  • Qualification/Validation Master plans are up to date and established for all ongoing projects in QC
  • Plan, coordinate and execute all phases for qualification of GMP manufacturing systems including but not limited to, Qualification/Validation plans, FMEA, DQ, IQ, OQ, PQ.
  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
  • Coordinate and execute FAT/SAT, commissioning activities for new manufacturing systems in collaboration with internal and external partners
  • Coordination and oversight of external suppliers
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification topics

EXPERIENCE & EDUCATION :

  • Academic degree(s)
  • First experience in C&Q in the pharmaceutical, biotech, chemical or similar industries
  • You have good analytical and synthesis skills as well as diligence and team spirit
  • Fluency in English is required, German or French would be an asset.

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.

WHAT WE OFFER:

  • A permanent contract and innovative projects
  • An attractive remuneration policy
  • Personalized management and continuous learning to develop your career
  • Great team spirt and an integration within the "Tribe"

If you want to join a dynamic and ambitious company? Altogen is made for you. Send us your application.