Junior Computer System Validation (CSV) Engineer
Descrizione dell'offerta
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