Beschreibung
Validation Engineer
A top 10 Pharmaceutical company based in the German region of Switzerland are looking for a Qualification & Validation Engineer in IT/Equipment to join their company on a 9 Month project.
Responsibilities:
- Transition from laboratory systems to Windows 7 with corresponding re-qualification of the systems.
- Create/adjust the qualification protocols to Client Standard (URS, IQ, OQ).
- Coordination of equipment installation with the relevant laboratories specialist and IT team. Implementation and documentation of IQ tests according to specifications.
- Assistance in the implementation of the OQ tests according to specifications (together with laboratory and external specialists).
- Creating the qualification reports to Client Standard (IQ, OQ, summary report).
- Adjusting the master data in SAP-PM database.
- Create/adjust maintenance requirements.
Requirements:
- Previous experience of relevant laboratory equipment: Photometer, DSC, cIEF, titration devices, density meters, TOC, particle counter, NIR
- Science studies or chemistry laboratory with at least 2 years experience in a GMP environment.
- At least 1 year experience in qualification of equipment in a GMP Environment including 21 CFR Part 11
- Very good German and good English skills in speaking and writing.
- Very good understanding of IT