CSV Engineer

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Job Responsibilities

• Create the requested CSV documents according to the client SOP
• Execute the CSV test and support the CSV timelines with PM & CQV-Lead
• Close interaction with Process Engineers, Automation Team (EMR), PM and QA
• Forcing the clients CQV/CSV approach during the entire project
• Acting as subject matter expert (SME) on following the clients CQV / CSV standards
• CSV person of contact of the assigned system till the handover to the operation organisation
• 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 clients SOP's and Guidelines
• Organise the reviews of the CSV documents till last QA approval
• Create the tests protocols and execute the tests
• Close collaboration with CSV Lead and CQV Lead Engineers
• Supervision for 3 employees (including contractors)

Skills and Requirements

• Technical degree (Bachelor) in engineering or applied science, post graduate qualification preferred.
• Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects
• With biologics (mammalian, CGT)
• Chemical manufacturing technologies desirable
• Expertise in automation and vertical integration as well as data management under validated computer systems
• Versed with planning CQV activities, leading large senior reports and high understanding/management of KPIs in regulated pharmaceutical industry and/or engineering company
• 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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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