Description
We are looking for a
Qualification and Validation Engineer (m/f)
Reference: -en
Start: 03/16
Duration: 10 MM
Place: in the Bern region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure 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
- Ensure 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, DQ, IQ, OQ
- Prepare, review and approve technical and GMP-related documentation (URS, qualification documentation) Liaise with cross-functional teams handling preventive maintenance, equipment calibration and repair, and ensure equipment readiness for production
- Coordinate the commissioning activities for new equipment production with finance, engineering and EHS, and support the user in issuing URS
- Support engineering, quality and production in a campus-wide qualification/validation team and coordinate equipment tracking
- Coordinate and execute FAT/SAT, commissioning activities in collaboration with internal and external partners
- Operational handling of change controls, CAPAs and non-conformances related to process equipment and cleaning
- Authoring of work instructions, SOPs and technical presentations
Your qualifications
- University degree in natural or technical sciences or equivalent
- Profound working experience within a pharma or a biotech company
- 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 essential
- Furthermore we are looking for a team player, self-starter, multitasker with good time management
Skills:
- Qualification/validation specialist