CSV Engineer

As a CSV Engineer, you will work at the heart of our clients’ projects, ensuring that computerized systems are validated and maintained in a compliant state throughout their lifecycle, in accordance with GMP, GxP and Data Integrity requirements.

Depending on your experience and area of expertise, you may be responsible for:

• Defining and implementing Computerized System Validation strategies;
• Preparing, reviewing and executing validation documentation such as URS, Risk Assessments, Validation Plans, IQ, OQ, PQ and Validation Reports;
• Performing GxP and system impact assessments;
• Defining and executing risk-based validation approaches;
• Reviewing and approving test protocols, test results and validation evidence;
• Managing deviations, discrepancies and CAPAs related to validation activities;
• Assessing system changes and ensuring continued validated status through change control;
• Supporting Data Integrity and compliance assessments;
• Ensuring compliance with applicable GMP/GxP requirements and industry standards;
• Collaborating with key stakeholders including Quality, IT, Automation, Engineering, Production, system owners and suppliers;
• Supporting computerized systems throughout their lifecycle, from implementation to operation and retirement., You become part of a genuine ecosystem of expertise, designed to help you make a meaningful impact on the projects you contribute to:

A strong community of consultants and experts to share knowledge, discuss technical challenges and leverage field experience;

A Knowledge Management environment designed to develop, structure and share expertise across the Group;

Digital & AI tools supporting our consultants in tackling complex challenges more efficiently;

A career path tailored to your ambitions, whether you want to deepen your technical expertise or progress towards coordination, project management, subject matter expertise or leadership roles;

A wide variety of projects and technical environments with leading pharmaceutical and biotechnology companies.

Our ambition goes beyond placing you on a project: we want to give you the environment, expertise and opportunities to grow and build your career over the long term.

Ready for your next challenge?

Would you like to join a community of experts and contribute to complex, high-impact validation and digital projects within the Life Sciences industry?

• A scientific or technical degree in Engineering, IT, Computer Science, Life Sciences, Pharmacy or equivalent;
• First successful experience or several years of experience in Computerized System Validation (CSV) within a regulated environment;
• Previous experience within the pharmaceutical or biotechnology industry;
• Good understanding of GMP / GxP requirements and Data Integrity principles;
• Knowledge of the computerized system validation lifecycle and associated documentation;
• Familiarity with GAMP 5 and risk-based validation principles;
• Knowledge of 21 CFR Part 11 and EU Annex 11 is a strong asset;
• Ability to work effectively within multidisciplinary teams involving Quality, IT, Engineering, Automation and Business stakeholders;
• Strong analytical skills, autonomy, attention to detail and a quality-driven mindset;
• Good command of English; French and/or Dutch is an asset depending on the project.

Whether you are a junior, experienced, senior or specialized CSV professional, we would be happy to hear from you.

Efor is a leading consulting group specialized in Life Sciences, bringing together more than 3,200 consultants and experts and supporting over 1,000 clients worldwide, including 90% of the leading pharmaceutical, biotech and medtech companies., Join EFOR and let’s build the next step of your career together.