CSV Lead

Are you a CSV Lead interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: CSV Lead

Location: Visp, Switzerland

Rate: Open

Openings: 1 Lead

Contract/Perm: Contract (12-Months)

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.

Responsibilities:

Supporting assigned project(s) in Visp as CSV-Lead:Generating and Planning the CSV timelines with PM & CQV-LeadDefine and assign the needed amount of needed CSV staffClose interaction with Process Engineers, Automation Team (EMR), PM and QALeading the assigned CSV TeamForcing the Lonza CQV/CSV Approach during the entire project
• Provide leadership of CSV activities in assigned Project(s) at Visp (together with PM, Process Engineers, EMR and QA):
• Acting as subject matter expert (SME) on following Lonza CQV / CSV standards:
  • Correct CSV project staffing, expertise and coaching to the CSV staff assigned to projects
  • Initiate necessary training on CSV-Staff / Project staff on CQV and CSV (supported by local CQV -Staff)
  • Keeping oversight on Lonza CQV -standards, -timelines (etc.)
  • Address immediate time/quality constraints and act adequately
  • Force RFT thinking and approach
  • Considering EHS Requirements
• 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 CQV Lead
  • 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
  • Participate in inspection as Lonza Project CSV-representative

Requirements:

• Technical degree (bachelor level) 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
• 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
• Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable
• Proven management experience in an EMA / FDA regulated environmental
• Experience in People Management (internal and external) with respect to organizational aspects, coaching and development
• Strong knowledge of ISPE GAMP5 and ASTM guidelines with proven experience on large
• and complex projects
• Significant experience in automation
• Expertise in vertical integration and data management under validated computer systems.
• Very good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation
• Solid collaboration and influencing skills and the ability to work together with teams and individuals in a highly matrix environment

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

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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