Qualification and Validation Engineer

Vor Ort
6 months
Experis AG
flag_no Schweiz

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Qualification and Validation Engineer - Bern - 100%

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

For our international client based in Bern, Experis is currently looking for a Qualification and Validation Engineer for a contracting position of, at least, 6 months.

Tasks & Responsibilities:

* In charge of validation/qualification activities for 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
* Prepare, review and approve technical and GMP related documentation (URS, qualification documentation)
* Supporting the commissioning activities for new equipment and supporting the user
* 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

You bring for this role the following qualifications:

* Bachelor/Master Degree in technical or natural sciences
* A minimum of 3 years of working experience within pharma or a biotech company
* Experience in the pharma/biotech Fill Finish environment is a plus
* Basic Know-how of biotechnology processes
* Profound Know-how of Validation/Qualification requirements according to GMP
* Know-how of quality assurance principles
* Analytical thinking and problem solving ability
* Business fluency in German and English

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt.