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CSV Engineer

  • Location: Visp, 123
  • Salary: attractive rate
  • Job Type:Contract

Posted 1 day ago

  • Sector: Advanced Facilities
  • Contact: Imane Ghaffor
  • Contact Email: imane.ghaffor@nrl.co.uk
  • Contact Phone: 01483 302 133
  • Start Date: 20 December 2024
  • Expiry Date: 19 January 2025
  • Job Ref: V-195162-1
Background:

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

  • Create the requested CSV documents according to the client’s 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
Responsibilities:

80%

  • Acting as subject matter expert (SME) on following client’s 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 client’s environment
  • Create the requested CSV documents according the client’s 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
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 client’s continuous improvement vision

5%

  • Participate in inspection as client’s Project CSV-representative
5% FDeputizing 

Candidate Profile:


-Technical degree (bachelor level) in engineering or applied science, post graduate qualification preferred


-Significant experience in automation 


-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 environmental 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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