Regulatory Engineer- Medical Devices
Pubblicato il 04-08-2026 - Quanta Consultancy Services in Italia
CSV Engineer - Milan, Italy - 12 Month Contract
Our client is a leading global CDMO providing end‑to‑end pharmaceutical development and manufacturing services. Its expertise spans from APIs to finished drug products, supporting pharmaceutical and biotech companies in bringing medicines to market. Drafts and reviews validation documentation, including technical reports, for computerised system validations.
Reviews SOPs, specifications, and production documents in compliance with GMP and company procedures.
Reviews validation activities of computerised systems used in different departments, ensuring consistency with GMP requirements.
Writes and reviews procedures related to computerised system validation.
Supports, within the validation group, the operators performing tests to ensure computer system validation activities.
High school diploma and/or degree in scientific subjects.
Extensive experience in a similar role.
Good knowledge of GMP.
Good knowledge of English for documentation purposes and participation in customer and regulatory audits.
Client‑Server architectures, standalone systems, backup & restore, access and profile management, laboratory systems (LIMS; Empower), production systems (SCADA).