Validation and Qualification Engieer

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.

Responsibilities:

- 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

Requirements:

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.