Senior Validation Engineer
Vor 2 Tagen
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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