CSV (Computer System Validation) Engineer - Life Sciences

-; Seregno; In loco; EUR 35.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading life sciences company is seeking a junior CSV Engineer in Seregno, Italy. This role involves fostering a quality culture in pharmaceutical projects and supporting validation activities. The ideal candidate has a technical degree and up to 2 years of experience in pharmaceutical environments. Proficiency in English and Italian is required, as well as a willingness to travel. Join us to make an impact from day one in a dynamic environment.

Competenze

• Up to 2 years of experience in pharmaceutical plant environments.
• Proficiency in English and Italian language.
• Open to travel to customer sites (30%).

Mansioni

• Foster a strong quality culture and ensure alignment to procedures.
• Develop test strategies, plans, and support execution.
• Assist in project quality reporting and track issues.

Conoscenze

Communication

Risk management

Collaboration

Attention to detail

Formazione

Technical degree (MSc preferred)

Strumenti

GAMP

Descrizione del lavoro

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. With experience within pharmaceutical environment and automation projects related to Distributed Control Systems (DCS), Lifecycle Services, and Software Solutions you will play a key role in developing and maintaining Quality Systems for life‑science industry projects. We are looking for someone who will act as the Quality "voice," supporting both project teams and the wider department to ensure high standards and compliance are consistently achieved. This role is ideal for someone eager to grow and develop with the support of an experienced colleague, offering opportunities to learn and collaborate at a European level.

Let’s go! We are eager to train you and support you as you grow into a key quality champion for life‑science projects, shaping processes, ensuring compliance, and making an impact from day one.

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.

No calls or agencies please.