Computerized System Validation (CSV) Engineer (M/F)
About the company
MEENT is a leading company in the life sciences field, offering solid expertise in engineering consulting and clinical research. Our commitment to innovation and quality allows us to provide tailored solutions in response to the complex challenges of our clients in the Healthcare sector.
Your tasks
As part of our business development, we are looking for a Computerized System Validation (CSV) Engineer to work on large-scale projects for our clients in the pharmaceutical, biotechnology, and medical device sectors.
- Lead the validation of computerized systems in a GxP environment: LIMS, MES, ERP, GMAO, SCADA supervision systems, laboratory equipment software, etc.
- Write validation deliverables: validation plans, URS, risk analyses, IQ/OQ/PQ protocols and reports, traceability matrices.
- Prepare and execute tests, document results, and ensure the follow-up of associated deviations.
- Guarantee system compliance with applicable regulatory frameworks: GAMP 5, 21 CFR Part 11, GMP Annex 11, and Data Integrity principles (ALCOA+).
- Participate in change control management, periodic reviews, and maintaining the validated state of systems.
- Collaborate with various stakeholders: IT teams, Quality, Production, users, and suppliers.
- Contribute to the continuous improvement of validation processes and practices.
Requirements
- Graduate with a Bac+5 (engineering school or Master's degree) with a focus on science, IT, quality, or equivalent.
- You have a successful first experience of at least 3 years in an industrial environment.
- You have a good knowledge of GAMP 5, 21 CFR Part 11, Annex 11 frameworks, and requirements related to Data Integrity.
- Knowledge of or sensitivity to the CSA (Computer Software Assurance) approach is a plus.
- You are recognized for your rigor, analytical skills, and writing abilities.
- You have good interpersonal skills and are comfortable working with stakeholders from different professions.
- You are proficient in technical English, particularly for reading and writing documentation.
What we offer
Do you want to put your expertise in computerized system validation at the service of innovative and high-stakes projects in Life Sciences?
Join Meent and develop your expertise alongside our teams, while working on large-scale projects for major players in the pharmaceutical, biotechnology, and medical device sectors.
Other
The position is based in Bourgogne-Franche-Comté, depending on projects and our clients' needs.