CSV (Computer System Validation) Engineer - Life Sciences

Are you a professional looking for a new challenge in a dynamic and fast developing business? We invite you to join our team as a CSV (Computer System Validation) Engineer - Life Sciences to be based in Seregno, Italy within the Systems and Solutions organization.

In This Role, Your Responsibilities Will Be

• Foster a strong quality culture within the Manufacturing Execution System and DeltaV life-science project team, ensuring alignment to procedures and clarity on individual responsibilities
• Provide compliance and risk management guidance, supporting the development of strategies to mitigate project risks
• Develop test strategies and test plans, train testers including customers, support test execution, collect evidence, and prepare test reports
• Ensure focus on user requirements, coordinate project traceability, and review project documentation including functional specifications, configuration specifications, design specifications, and test specifications
• Assist in project quality reporting, track quality issues, and support solutions
• Support the preparation and communication of project quality plans, lessons learned, and other quality-relevant documentation
• Develop, implement, and enforce document control, configuration management, and change management procedures on projects
• Participate in project quality audits and support the Computer System Validation Lead Engineer and Quality Department in maintaining schedules and tracking outcomes

Who You Are

You are a junior professional with hands‑on experience in life science projects, eager to support validation activities and ensure alignment. You actively listen, adapt your communication to meet the needs of diverse partners, and anticipate customer needs to deliver services beyond expectations. You leverage customer insights to guide improvements and new offerings, and you collaborate effectively to help others across the organization achieve shared objectives. You have a technical background and a strong focus on delivering accurate, high‑quality results in a regulated environment.

For This Role, You Will Need

• Technical degree or equivalent (MSc preferred, Engineering or Pharmaceutical/Biomedical background a plus)
• Up to 2 years of experience in pharmaceutical plant environments
• Knowledge of computer system validation (GAMP) and all validation activities in pharma projects
• Experience supporting validation master plans, reviewing customer documentation, and supervising testing (FAT, SAT)
• Proficiency in English and Italian language
• Open to travel to customer sites (30%)
• Driving licence

Preferred Qualifications that Set You Apart

• Ability to work within a complex matrix organization and collaborate across business units
• In‑depth knowledge of pharma industry
• Knowledge of current pharmaceutical industry regulations and standards for computerized system validation is a plus

Accessibility Assistance or Accommodation

If you have a disability and are having difficulty accessing or using this website to apply for a position, please contact: .

No calls or agencies please.

#J-18808-Ljbffr