Global CSV & Data Compliance Specialist (Hybrid)

Product Life Italia Srl, Scandicci, succursale di Lugano; Scandicci; Hybrid; EUR 35,000 - 45,000; Full time

Job summary

ProductLife Group in Italy is seeking a CSV Validation Specialist to support validation projects across the life sciences sector. You will plan and execute validation activities in line with GAMP 5, GMP, Annex 11, and 21 CFR Part 11 to ensure system readiness and compliance.

You will prepare validation documentation, support data integrity, and work with QA, IT, Engineering, and Manufacturing teams to deliver compliant systems on time. Some travel may be required.

Qualifications

• Bachelor or Master in Engineering, IT, Life Sciences, Pharmacy, Chemistry or related field.
• 4-5 years of experience in CSV/validation in life sciences.
• Fluent Italian and English.
• Knowledge of GxP and GMP requirements for computerized systems.
• Strong documentation and validation lifecycle skills.
• Willingness to travel where required.

Responsibilities

• Plan, coordinate, and execute CSV activities for client projects per GAMP 5, GMP, Annex 11, and 21 CFR Part 11.
• Prepare, review, manage validation docs including VMPs, URS, IQ/OQ/PQ, and reports.
• Support data integrity compliance per ALCOA+ and regulatory requirements.
• Perform risk assessments to define validation strategies and regulatory alignment.
• Collaborate with QA, IT, Engineering, Manufacturing, QC, and Validation teams.
• Draft and update SOPs and GMP documentation; support audits and inspections.

Skills

GxP regs

GAMP 5

EU GMP Annex 11

21 CFR Part 11

CSV lifecycle

SDLC

MS Office

Regulatory compliance

Education

Bachelor's or Master's in Engineering/IT/Life Sciences

Job description

ProductLife Group in Italy is seeking a CSV Validation Specialist to support validation projects across the life sciences sector. You will plan and execute validation activities in line with GAMP 5, GMP, Annex 11, and 21 CFR Part 11 to ensure system readiness and compliance.

You will prepare validation documentation, support data integrity, and work with QA, IT, Engineering, and Manufacturing teams to deliver compliant systems on time. Some travel may be required.