Senior Validation Engineer

Vor 2 Tagen


Orbe, Waadt, Schweiz Axepta SA Vollzeit

We are looking for a Senior Validation Engineer - CSV to join our team at Axepta SA. As a key member of our quality assurance department, you will be responsible for ensuring the compliance of our automated and computerized systems with cGMP and applicable regulations.

Main Responsibilities:

  • Act as the main point of contact for quality compliance key topics regarding automated and computerized systems.
  • Review and approve URS and relevant design documentation.
  • Support risk assessment exercises and ensure the qualification and validation of all systems in close collaboration with process engineering & automation teams.
  • Create SOPs for Automated and Computerized systems qualification / validation including 21CFR part 11 and data integrity requirements.
  • Perform quality audits for computerized and automated systems suppliers if needed.

Requirements:

  • Minimum of 5 years experience in a quality assurance engineering role in a biopharmaceutical manufacturing environment or medical devices.
  • Experience in computerized and automated systems (MES, PLC SCADA systems, EMS, LIMS, ERP systems).
  • English and French language proficiency.

We are looking for a motivated and experienced candidate to join our quality assurance team. If you are passionate about ensuring the quality of our automated and computerized systems, please apply.


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