Validation - Computer System Validation (CSV) Specialist
Descrizione dell'offerta
We are looking for an experienced Validation / Computer System Validation Specialist to join the Quality Validation team at our Cisterna di Latina manufacturing site , supporting validation activities across production processes and GxP computerized systems.
What you will do:
- Execute qualification and validation activities for equipment, utilities, processes and cleaning
- Manage Computer System Validation (CSV) for systems such as LIMS, ERP and MES
- Ensure compliance with GxP, Data Integrity, 21 CFR Part 11, EU GMP Annex 11 and GAMP5
- Perform risk assessment, gap analysis, deviation/CAPA and change control management
- Prepare and review validation documentation and SOPs
- Support internal/external audits and collaborate with Engineering, IT, Quality and R&D teams
- Monitor validation KPIs and contribute to continuous improvement initiatives
What we are looking for:
- Scientific Master’s Degree (Engineering, Computer Science, Chemistry, Biotechnology or similar)
- 2–4+ years of experience in Validation and CSV in pharmaceutical or medical device multinational environments
- Experience with GxP computerized systems validation lifecycle
- Strong technical writing skills and good English proficiency
- Availability to travel occasionally
You will be part of a multisite corporate validation team , working in a highly automated pharmaceutical manufacturing environment with real impact on product quality and compliance.