CSV (Computer System Validation) Engineer - Life Sciences

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

Descrizione del lavoro

A leading life sciences company based in Seregno is seeking a CSV Engineer to support quality systems in the pharmaceutical sector. You will lead compliance efforts, develop test plans, and promote a strong quality culture within projects. Ideal candidates should have a technical degree, up to 2 years of experience in pharma environments, and proficiency in English and Italian. This role offers a dynamic work environment with opportunities for growth and development.

Competenze

• Up to 2 years of experience in pharmaceutical environment.
• Knowledge of computer system validation (GAMP) and validation activities.
• Proficiency in English and Italian language.

Mansioni

• Foster quality culture within project teams.
• Provide compliance and risk management guidance.
• Develop test strategies and plans, support test execution.

Conoscenze

Communication

Risk Management

Team Collaboration

User Requirement Focus

Formazione

Technical degree or equivalent (MSc preferred)

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, Software Solutions you will be playing 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 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.

Responsibilities

• 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.

Requirements

• 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

• 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

Culture & Commitment

At Emerson, we prioritize a workplace where every employee is valued, respected, and empowered to grow. We foster an environment that encourages innovation, collaboration, and diverse perspectives-because we know that great ideas come from great teams. Our commitment to ongoing career development and growing an inclusive culture ensures you have the support to thrive. Whether through mentorship, training, or leadership opportunities, we invest in your success so you can make a lasting impact. We believe diverse teams, working together are key to driving growth and delivering business results.