CSV Engineer (m/f/d)
Responsibilities
- Acting as subject matter expert (SME) on following Lonza 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 Lonza environment
- Create the requested CSV documents according Lonza 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
Profile
- 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
- 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
Benefits
- Further training oppurtunities
- Friendly working enviroment
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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