Réf. : ALTO-CH-CQVE 23/12/2021
context
Localisation
Lausanne (VD)
Start date
Ideal profile
Educational background
Academic degree(s) with focus in qualification/ validation or any other related field.
Fluency in English and French are required, German would be an asset.
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Experience
First experience in commissioning or qualification in the pharmaceutical, biotech, chemical or similar industries.
You have good analytical and synthesis skills as well as diligence and team spirit.
Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.
Proposed project
To strengthen our team in Switzerland, we are currently looking for a Commissioning & Qualification Engineer (m/f/x) to start asap.
About the job :
As a Commissioning & Qualification 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.
- In charge of commissioning and qualification (C&Q) activities for Technical Services department in order to ensure that:
- 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.
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.