CQV Engineer

Titre du poste : CVQEngineer (H/F/D)

Lieu :Toulouse

Département :MSAT/CQV

Relève de :Directorof MSAT

Type decontrat:CDI

We aredelightedtoinformyouthatthisopportunityispart ofSandoz’sacquisition of Just-EvotecBiologicsin Toulouse. Thisrolewillallowyou tomakeadifferencein thelivesofhundredsof millions of peoplethroughboldideassupportedby an inclusive and agilecorporateculture.Joinus to helpmakehealthcaremoreequitableandfaster, and help uspioneeraccesstomedicines!Click to learn more.

WhatYou’llDo:

• Lead andreviewkey CQVdeliverables(URS,riskassessments, DQ, RTM, FAT/SAT, IQ/OQ) formanufacturing,facilities, utilities, andcleaningsystems.

• Ensureprocessesareproperlydefinedandqualifiedacrossthe validationlifecycleusingarisk-basedapproach.

• Collaboratewithcross-functionalteams(Engineering, Automation, E&HS,Quality) andexternalpartnersto driveprojectexecution.

• Support CQVactivitieson theground(FAT, SAT, Commissioning, IQ/OQ)ensuringsystemsmeetrequirements.

• Managedeviations,includingtroubleshooting and root causeanalysis.

• Ensuretimelydeliveryof CQV documentation andmaintainprojectschedule.

• Performperiodicreviewsand requalification toensureongoingcompliance.

• Support auditreadinessandcontributetoresponsestoregulatoryinspections.

This role offers the opportunity to play a critical part in delivering compliant, high-quality systems that directlyimpactpatient safety and product quality in a highly regulated environment.

WhoYouAre:

• Engineeringdegree(Master’spreferred)with~8–10yearsofexperiencein CQV/validationwithinregulatedenvironments.

• Strong expertise in qualification and validation ofequipment, utilities, andfacilities,applyingscience- andrisk-basedapproaches.

• Provenexperienceauthoringandreviewingvalidation documentation,withsolidknowledgeofqualityriskmanagement andregulatoryrequirements(FDA, EMA, ICH).

• Goodunderstandingof processequipment, utilities, automationsystems(e.g.,DeltaV), and engineeringprinciples.

• Hands-onexperienceincleaningvalidation (sampling techniques, cycledevelopment, MACOcalculations) andsupportingNew Product Introduction (NPI).

• FamiliarwithComputerSystemsValidation (CSV) and qualification of QCequipmentandsystems.

• Strongproblem-solving,criticalthinking, and attention todetail,withtheabilitytomanageprioritiesin a fast-pacedenvironment.

• Effectivecommunicatorin English (Frenchisa plus), able toworkbothindependentlyandcollaborativelyacrossmultidisciplinaryteams.

WhySandoz?

Generic and Biosimilarmedicines are the backbone of the global medicinesindustry. Sandoz, a leader in this sector, provided more than 900 million patienttreatmentsacross100+ countries in 2024 andwhilewe areproudof thisachievement, we have an ambition to domore!

Withinvestments in new developmentcapabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-qualitymedicines, sustainably. 

Our momentum and entrepreneurial spirit ispowered by an open, collaborative culture driven by our talented and ambitiouscolleagues, who, in return for applyingtheirskillsexperience an agile and collegiateenvironmentwithimpactful, flexible-hybridcareers, wherediversityiswelcomed and wherepersonalgrowthisencouraged! 

The future is ours to shape!