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 to 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
Qualifications:
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 environment 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 opportunities
Friendly working environment
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