Qualification and Validation Engineer – Biotech
We are looking for a qualification and validation engineer to join a team and focus on task related to equipment and processes validation.
* Develop and execute qualification master plans
* 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
Bachelor/Master Degree in technical or natural sciences already gained working experience within pharma or a biotech company Experience in the pharma/biotech Fill Finish environment Basic Know-how of biotechnology processes Profound Know-how of Validation/Qualification requirements according to cGMP Know-how of quality assurance principles Analytical thinking and problem solving ability Business fluency in German and English is a must
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.