CSV Validation Specialist - Data & Compliance (Hybrid)

PLG; Scandicci; Hybrid; EUR 35,000 - 45,000; Full time

Job summary

ProductLife Group is hiring a Validation Specialist (Data and Compliance) to plan, coordinate, and execute CSV activities for client projects. You will ensure compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11, while preparing validation documentation and supporting Data Integrity under ALCOA+ principles.

You will work with QA, IT, Engineering, Manufacturing, QC and Validation teams to manage risk, change control, deviations, CAPAs, and lifecycle activities for computerized

Qualifications

• Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field.
• 4-5 years of experience in validation/compliance or related field.
• Italian and English language proficiency.

Responsibilities

• Plan, coordinate, and execute CSV activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11 and 21 CFR Part 11.
• Prepare, review, and manage validation docs: VPs, RA, URS, IQ/OQ/PQ protocols, and Validation Reports.
• Support Data Integrity compliance per ALCOA+ principles and regulatory requirements.
• Assist in risk assessments to define validation strategies and regulatory compliance.
• Support Change Control, Deviations, CAPAs, periodic reviews, and lifecycle activities for computerized systems.
• Collaborate with QA, IT, Engineering, Manufacturing, QC, and Validation teams to deliver projects on time and within quality standards.
• Assess impact of software implementations and changes on validated systems.
• Draft/update SOPs and Validation Master Plans for client projects; assist during internal and supplier audits.

Skills

GxP regulations

GMP requirements

CSV lifecycle

SDLC

Microsoft Office

Attention to detail

Team collaboration

Problem solving

Interpersonal skills

Travel availability

Education

Bachelor's or Master's degree in Engineering or Life Sciences or related field

Tools

Microsoft Office Suite

Job description

ProductLife Group is hiring a Validation Specialist (Data and Compliance) to plan, coordinate, and execute CSV activities for client projects. You will ensure compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11, while preparing validation documentation and supporting Data Integrity under ALCOA+ principles.

You will work with QA, IT, Engineering, Manufacturing, QC and Validation teams to manage risk, change control, deviations, CAPAs, and lifecycle activities for computerized