CSV Lead

☞ PharmiWeb.Jobs

Vue: 176

Jour de mise à jour: 20-03-2024

Localisation: Zermatt Valais VS

Catégorie: Autre

Industrie: Research Biotechnology Pharmaceuticals

Niveau: Associate

Type d’emploi: Full-time

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le contenu du travail

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-Lead

Define and assign the needed amount of needed CSV staff

Close interaction with Process Engineers, Automation Team (EMR), PM and QA

Leading the assigned CSV Team

Forcing 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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Date limite: 04-05-2024

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