Senior csv consultant

Are you ready to join a global leader in the exciting and dynamic fields of pharmaceuticals and medical devices?


PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees across Europe, Asia and the Americas.


Due to our continuous growth, we are currently looking for a Senior CSV Consultant to support one of our key projects based in Lille, France.


This is a permanent position. Freelance or contract applications will not be considered.


You will be responsible for

* Leading and executing Computer System Validation (CSV) and Data Integrity projects, ensuring compliance with GxP regulations, including 21 CFR Part 11, EU GMP Annex 11, and other relevant regulatory guidelines
* Collaborating with cross-functional teams including IT, Quality Assurance, and Regulatory Affairs to ensure successful project execution
* Developing and executing a strategic CSV plan aligned with company compliance and quality objectives, including validation strategies, risk assessment methodologies, and validation lifecycle models
* Overseeing the development and review of validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices
* Conducting risk assessments for computerized systems, identifying vulnerabilities and implementing risk mitigation strategies
* Establishing and maintaining change control processes to manage system changes and updates in compliance with validation requirements
* Providing guidance on validation testing methodologies, including test design, execution, and documentation, ensuring that testing meets regulatory expectations
* Training and mentoring junior consultants and client staff on CSV principles, validation processes, and compliance practices


About you

* Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or a related field
* Minimum 4 years of experience in Computer System Validation within the pharmaceutical or life sciences industry
* Strong knowledge of GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11
* Proven experience leading or coordinating CSV projects
* Strong analytical and problem-solving skills
* Excellent communication and collaboration skills, particularly in consulting or client-facing environments
* Fluent English (minimum B2 level)
* Fluent French (minimum C1 level)
* Ability to work in a hybrid environment with onsite presence in Lille 3 days per week


Next Steps

Upon receiving your application, if a match is found, the Recruiting Department will contact you for an initial HR interview.

If the outcome is positive, a technical interview with the Hiring Manager will be arranged.

Following a successful interview with the Hiring Manager, the recruiter will contact you to discuss the next steps or present our proposal.

If the outcome is negative, we will inform you accordingly and close the recruitment process.


Working at PQE Group

As a member of the PQE team, you will be part of a stimulating, multicultural company that values collaboration and innovation. PQE Group offers the opportunity to work on international projects, develop your expertise, and collaborate with colleagues from across the world.

If you are looking for a rewarding and exciting permanent career opportunity in Lille, France, PQE Group is the perfect place for you.

Apply now and take the first step toward an extraordinary future with us.