CSV Engineer – SAP Validation (GAMP 5) | Contract

Location: Mirandola (MO), Italy

Working arrangement: on-site preferred, otherwise at least 3 days on-site and 2 days remote

Duration: ASAP to 28/04/2028

About the job:

We're looking for a CSV Engineer with SAP validation experience to plan, execute and document validation activities in a regulated GxP environment. You'll work with business users, SAP consultants and system integrators on SAP implementation, upgrade and migration projects, ensuring compliance with GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity requirements.

Key responsibilities:

• Define and execute Computer System Validation activities following GAMP 5
• Prepare and review validation documentation: VP, URS, FS, DS, risk assessments, IQ/OQ/PQ protocols, traceability matrix and validation reports
• Assess the GxP impact of SAP functionalities and configurations, and support the validation of data migration
• Verify user roles, authorisations and electronic records and signatures compliance
• Develop and execute test scripts, coordinate UAT, and manage deviations, CAPAs and change controls

Skills required:

• 3+ years of Computer System Validation experience in regulated industries
• Experience in SAP validation projects within GxP-compliant environments
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and data integrity (ALCOA+)
• Experience with risk-based validation and Computer System Assurance (CSA) principles
• Degree in Engineering, Computer Science, Pharmaceutical Sciences, Biotechnology or Life Sciences, with Italian as main language and good written and spoken English

Have questions? Connect with me on LinkedIn or email me at matteo.biasio@sapcontractors.com. I'm also happy to hear about anyone you think could be a fit for the role.

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