CSV Engineer (m/f/d)
- Acting as subject matter expert (SME) on following CQV / CSV standards
- CSV person of contact of the assigned system till the handover to the operation organization
- Participate to the system impact assessment as CSV SME
- Define with EMR and Package Units vendor the most appropriate design for vertical integration in the clients environment
- Create the requested CSV documents according to the SOP’s and Guidelines
- Organize the reviews of the CSV documents till last QA approval
- Participate to the FAT & SAT
- Create the tests protocols and execute the tests
- Close collaboration with CSV Lead or CQV Lead
- Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred
- Significant experience in automation
- Extensive experience in vertical integration and data management under validated computer systems
- Experience in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable
- Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs
- Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large and complex projects. Proven management experience in an EMA / FDA regulated environmental with very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation
- Experience in People Management (internal and external) with respect to organizational aspects, coaching and development
- Excellent command of English; German nice to have
- Further training opportunities
À propos de l'entreprise