Validation Specialist (Data And Compliance)

ProductLife Group; Scandicci; On-site; EUR 35,000 - 45,000; Full time

Job summary

ProductLife Group is seeking an experienced CSV and validation professional to impact global healthcare. The role focuses on planning, executing, and coordinating Computerized System Validation activities for client projects in strict regulatory alignment with GAMP 5, GMP, Annex 11 and 21 CFR Part 11.

You will prepare validation documentation, support data integrity, perform risk assessments, and drive lifecycle activities in collaboration with QA, IT, Engineering, Manufacturing and Validation

Qualifications

• Bachelor's or Master's degree in a related field.
• Strong knowledge of GxP and GMP requirements for computerized systems.
• Experience with CSV lifecycle and validation methodologies.
• Understanding of SDLC and lifecycle management for validated systems.
• Proficiency in MS Office tools (Word, Excel, PowerPoint).

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 documentation including validation plans, risk assessments, and validation reports.
• Support Data Integrity compliance according to ALCOA+ principles and applicable regulations.
• Perform risk assessments to define validation strategies and support regulatory compliance.
• Assist Change Control, Deviations, CAPAs and periodic validation lifecycle activities.
• Collaborate with cross-functional client teams to deliver validation projects on time and to spec.

Skills

GxP knowledge

CSV lifecycle

GAMP 5/Annex 11/Part 11

SDLC understanding

MS Office (Word/Excel/PowerPoint)

Attention to detail

Teamwork / collaboration

Education

Bachelor's or Master's in Engineering/CS/IT/Life Sciences/Pharmacy/Chemistry/Biotechnology

Tools

MS Office Suite

Job description

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Job Description

Specific activities and responsibilities:

• Plan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements.
• Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports.
• Support clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements.
• Perform risk assessments to define validation strategies and support regulatory compliance.
• Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems.
• Collaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects.
• Assess the impact of software implementations, upgrades, and changes on validated systems.
• Draft and update SOPs, Validation Master Plans (VMPs), and other GMP documentation for client projects.
• Provide validation and compliance support during internal audits, supplier audits, and regulatory inspections.
• Contribute to multiple client projects, ensuring delivery within agreed timelines, quality standards, and regulatory expectations.
• Required education:
• Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field

Required Experience

4-5 years of experience

Required Languages

Italian and English

Required Technical Skills

• Knowledge of GxP regulations and GMP requirements applicable to computerized systems.
• Good understanding of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
• Experience with Computerized System Validation (CSV) lifecycle and validation methodologies.
• Understanding of software development lifecycle (SDLC) and computerized systems lifecycle management.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Additional Experience And/or Skills

• Attention to detail
• Team working and proactivity
• Problem solving
• good Interpersonal skills
• customer management
• team management
• availability to travel is mandatory

Compensation range: €35000 - €45000

The compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, qualifications, and internal compensation policies, in accordance with applicable EU and local pay transparency and pay equity requirements.