CSV Engineer (80 to 100%) (M/F)
Permanent contract
Visp
07/17/2021
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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