Lausanne

CSV Specialist

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Information
  • Location: Lausanne
  • Position: CSV Specialist (M/F)
  • Sector: Life Sciences
  • Type of contract: Permanent contract
  • Starting date: ASAP

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. You are a permanent and valuable part of our teams, being supported by your designated technical business manager and a secure, stable work environment for you.

Your main missions are:

The CSV engineer is in charge of ensuring the validated state of computerized systems on
manufacturing site, including laboratory equipment.

  • Create the requested CSV documents: risk analyses, traceability matrixes, validation protocols.
  • Organize the review of the CSV documents by the QA teams.
  • Execute the CSV test and support the CSV timelines.
  • Write CSV reports.
  • Work in close collaboration with the CSV and CQV lead Engineers.
  • Interact closely with Process Engineers, Automation Team (EMR), PM and QA.
  • Ensure GAMP5 compliance, follow the ASTM guidelines.

This job is made for you if.

  • You hold an engineering diploma in Biotechnology, Bioprocess or Chemical Engineering, or similar.
  • You have a Minimum of 3+ years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects.
  • You have Expertise in automation and vertical integration as well as data management under validated computer systems.
  • You know planning CQV activities, leading large senior reports.
  • You have a 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.
  • You are fluent in French and English.

Working with us means.

  • Being an expert in a fast-paced and diverse environment.
  • Joining an organically fast-growing company.
  • Working in an agile company with startup feeling.
  • Joining a team guided by shared values, respect, trust and fun.
  • Meeting wonderful people and their network.
  • Facing technical challenges in changing industries.
  • Chance to speed up and improve your career.
  • Having choice of projects, follow ups and trainings.
  • Being valued and not just one of many.

 

For agap2, all talents count. If you have a disability, do not hesitate to ask questions and to apply.