Toulouse
Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries. PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. Due to our constant growth, we are looking for a CQV Engineer to support our projects in Toulouse, Occitanie, France. Location • Required: Toulouse area, France (Occitanie region), • Candidates based elsewhere in southern France (Montpellier, Bordeaux) may be considered if willing to relocate Experience • Years of experience: 3–7 years in qualification/validation in the pharmaceutical industry, • Max seniority level: Senior IC, • Background: Validation Engineer, Qualification Engineer, Commissioning & Qualification Engineer Must-Have Requirements • Qualification/validation experience: Minimum 3 years in IQ/OQ/PQ or IOQ qualification in a GMP pharmaceutical environment, • Protocol writing: Experience writing and executing qualification protocols and test reports, • Risk-based approach: Understanding of risk-based qualification methodology and quality risk management, • Pharmaceutical industry: Experience in a GMP-regulated pharmaceutical or biotech manufacturing environment, • Utilities / equipment knowledge: Understanding of process equipment, utilities (gas systems, HVAC, clean utilities), and engineering principles, • Language: French (professional proficiency required); English skills desirable Nice-to-Have Requirements • Direct experience with gas system qualification (nitrogen, compressed air, process gases, gas distribution panels/panoplies), • HVAC qualification experience (pressure differentials, air changes, smoke tests, cleanroom classification), • Experience with cleanroom/classified environments, • FAT/SAT experience, • Commissioning experience, • Deviation investigation and resolution experience, • Knowledge of ISPE guidelines, EU GMP Annex 15, FDA validation guidance, • Experience working with multidisciplinary teams (suppliers, process, automation, EHS), • Strong organizational and project tracking skills Keywords & Skills to Search For • Qualification, validation, IQ/OQ/PQ, IOQ, commissioning, • HVAC, CTA, traitement d'air, smoke test, delta pression, • Gaz, utilités, utilities, clean utilities, • Protocole de qualification, rapport de qualification, • GMP, BPF, analyse de risque, risk assessment, • Ingénieur validation, ingénieur qualification, C&Q, • Pharma, pharmaceutical, biotechnologie Next Steps Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE Group team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills, and collaborate with colleagues from around the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.