Validation Specialist (Data And Compliance)

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

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:

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.

PLG partners with Life Sciences innovators to bring new medicines and technologies to patients, faster.

Join a fast-growing, entrepreneurial company where your expertise makes a difference from day one.

A path for every career stage, from graduate to senior expert.

Exciting, high-impact projects with leading life sciences clients.

International by design.

Hybrid & flexible working.

Continuous learning.

An inclusive & diverse culture.