Work SiteSwitzerland / | CHE - All Regions / Basel
Contract TypePermanent [Full-Time]
Minimum number of years of experience required2 years of experience and more
Our offer
Integration in a solid and dynamic team.
Possibility to participate in international projects.
Participation in exciting and motivating projects.
Career evolution.
New challenges.
Your role
Provide Commissioning, Qualification and Validation (CQV) services to projects either independently or as part of a larger team.
Run Validation & Qualification projects and activities on client’s site.
Develop and execute Commissioning & Qualification lifecycle protocols as per the specific project requirements.
Generate documents such as master plans, design, installation and operational qualification protocols, equipment, facility and utility protocols, cleaning validation, computer validation, sterilization validation, data reviews, SOP development and development of final reports, whilst leading others in similar activities.
Supporting and representing the technical quality team in meetings, visits, troubleshooting exercises, and audits.
Your profile
Master degree in scientific or engineering discipline.
Ideally 3 to 7 years of experience in Qualification/Validation in the Pharmaceutical industry.
Sound knowledge in pharma industry regulations (GMP, GxP) and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Applied technical understanding of manufacturing equipment as black utilities, HVAC, clean utilities (WFI, Pure Steam, Pure Water, CAP loops).
Problem solving and troubleshooting skills.
English fluency is compulsory and German and/or French are good plus.
