CSV Engineer (80 to 100%) (M/F)

Permanent contract

Visp

07/17/2021

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Reference number

2021-18582

Category

Operations — Engineering/production

Business industry

Consulting

Minimum level of experience required

5 to 10 years

Location

Valais, Switzerland

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Job description

Location: Visp
Contract: Permanent with AKKA Switzerland
Starting date: September 2021
Languages: English C1, German is a plus
Swiss or European Union nationals

 

Tasks and Responsibilities:

  • Create the requested CSV documents
  • Execute the CSV test and support the CSV timelines with PM & CQV-Lead
  • Close interaction with Process Engineers, Automation Team and QA
  • Supervision for 3 employees (including contractors)
  • Create the tests protocols and execute the tests
  • 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.

Profile

Your Profile:

  • Minimum of 5+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects
  • People Management (internal and external) with respect to organizational aspects, coaching and development.
  • 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.
  • English C1, German is a plus

 

What working at AKKA has to offer:

  • A steady follow-up and career guidance.
  • A large network of collaborators across the world.
  • Several learning platforms and access to trainings.
  • Compelling challenges for prestigious and international clients.
  • Several dedicated events gathering all the collaborators and promoting corporate culture.

 

For more information, please contact me at maryline.fonteyne@akka.eu

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