? Hiring: CSV Engineer – SAP Validation (GAMP 5) | Mirandola, Italy ??

Are you an experienced Computer System Validation (CSV) Engineer looking to work on SAP validation projects within a highly regulated GxP environment? We are looking for a skilled professional to join an exciting opportunity in the pharmaceutical/life sciences sector.

? Location: Mirandola (MO), Italy (Candidate should be based in Italy)

? Work Model: Hybrid| Minimum 3 days onsite + 2 days remote

? Contract: Freelance/B2B

? Language Requirement: Italian (mandatory), English

Key Responsibilities

✅ Execute Computer System Validation activities following GAMP 5 methodology

✅ Create and review validation documentation (URS, FS, DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, Validation Reports)

✅ Support SAP implementation, upgrades, migrations, and enhancement projects

✅ Ensure compliance with:

- GAMP 5
- FDA 21 CFR Part 11
- EU Annex 11
- Data Integrity (ALCOA+)
- Computer System Assurance (CSA)

✅ Develop and execute validation test scripts ✅ Coordinate UAT activities





✅ Manage deviations, CAPAs, change controls, and defect resolution

✅ Ensure end-to-end traceability between requirements, risks, and testing evidence

Required Skills & Experience

✔️ 3-5+ years of Computer System Validation experience in regulated industries

✔️ Hands-on experience with SAP Validation Projects

✔️ Strong knowledge of GxP environments, Data Integrity, Risk-Based Validation, and compliance requirements

✔️ Excellent communication, stakeholder management, and problem-solving skills

Nice to Have

➕ Experience in pharmaceutical manufacturing

➕ Exposure to MES, LIMS, eQMS, SCADA, or Serialization systems

➕ Knowledge of Agile and CSA approaches

➕ PMP, ASQ, ISPE, or similar certifications

➕ Experience supporting FDA, EMA, or MHRA inspections

? Interested?

Apply directly,

send me a DM, or email your CV to [email protected]

📌 CSV Engineer – SAP Validation (Mirandola)
🏢 Hays
📍 Mirandola