15 ott - Mirandola
Hays
? 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 hidden)
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