CSV Global Engineer

Vor 2 Tagen

Visp, Schweiz Lonza Vollzeit

Supporting assigned project(s) in Visp as CSV-Engineer:

  • Create the requested CSV documents according to Lonza SOP’s
  • Execute the CSV tests
  • Support the CSV timelines with PM & CQV-Lead
  • Close interaction with Process Engineers, Automation Team (EMR), PM and QA

Forcing the Lonza CQV/CSV Approach during the entire project.

Responsibilities:

80%

  • 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 in 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 in the FAT & SAT
  • Create the test protocols and execute the tests
  • Close collaboration with CSV Lead or CQV Lead

10%

Responsible for ensuring that SGIE projects in Visp are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with Lonza’s continuous improvement vision.

5%

5%

Candidate profile:

  • Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred
  • Extensive experience in vertical integration and data management under validated computer systems.
  • Minimum of 5+ years 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 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.
  • Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment.
  • Language: Excellent command of English and proven knowledge in German necessary (read and write) and other desirable.
  • Strong analytical skills. Ability to conduct in-depth analysis of complex/large data sets, draw conclusions accordingly, and prepare and support decisions.
  • Experience at working both independently and in a team-oriented environment.
  • Ability to effectively prioritize and execute tasks in a fast-paced environment.
  • Strong written and oral communication skills.
  • Willing and able to train/support colleagues.
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