Junior Computer System Validation

2 giorni fa

Turin, Italia Meet Life Sciences A tempo pieno

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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