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Junior computer system validation (csv) engineer

Maserà di Padova
Contratto a tempo indeterminato
Stage
Meet Life Sciences
Pubblicato il 11 gennaio
Descrizione

Junior Computer System Validation (CSV) Engineer
Location: Verona, Italy
Full Time

About the Role
We are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology .
This role is ideal for someone who understands biology, laboratories, and regulated environments, but is equally enthusiastic about computer systems, data integrity, and how technology supports patient safety and product quality .
You will be trained and supported to build a career in CSV and GxP compliance, working on real validation projects within a regulated pharmaceutical or biotech environment.

Key Responsibilities
Support validation activities for GxP-regulated computerised systems (e.g. LIMS, QMS, MES, laboratory and equipment software)
Assist in the preparation, execution, and review of CSV documentation, including:
Risk Assessments (GAMP 5)
URS / Functional Specifications
IQ / OQ / PQ protocols
Participate in system testing, defect tracking, and traceability matrices
Support data integrity and compliance assessments
Work closely with Quality, IT, Automation, Engineering, and Laboratory teams
Assist with audit and inspection readiness activities
Maintain documentation in line with GMP, GAMP 5, EU Annex 11, and 21 CFR Part 11

Essential Requirements
Degree in Biomedical Science (or a very closely related life science discipline)
Strong interest and passion for computer science, IT systems, or technology
Demonstrable interest in how software and systems are used in regulated environments
Good written documentation and communication skills
Strong attention to detail and analytical thinking
Willingness to learn, ask questions, and work in a structured, regulated setting

Desirable (Not Essential)
Exposure to coding, scripting, data analysis, or computer science modules (academic or self-taught)
Internship, placement, or graduate experience in pharma, biotech, laboratories, or medtech
Awareness of GxP, GMP, GAMP 5, EU Annex 11, or FDA 21 CFR Part 11
Familiarity with systems such as LIMS, QMS, MES, or ERP
Interest in data integrity, automation, or digital transformation in life sciences

What We Offer
Structured training and mentoring in CSV and regulated systems
Hands-on experience with real GMP validation projects
A clear career pathway into CSV Engineer / Validation Engineer roles
Exposure to audits, inspections, and regulatory expectations
Competitive entry-level salary / rate
A supportive team environment that encourages learning and development

This Role Is Ideal For:
Biomedical Science graduates who are passionate about technology and computer systems
Candidates looking to combine life sciences with computer science
Graduates seeking a long-term career in CSV, validation, or quality systems

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