CQV Engineer

Titre du poste :CVQEngineer(H/F/D)

Lieu :Toulouse

Département :MSAT/CQV

Relève de :Directorof MSAT

Type decontrat:CDI

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

WhatYoullDo:

• Lead andreviewkey CQVdeliverables(URSriskassessments DQ RTM FAT/SAT IQ/OQ) formanufacturingfacilities utilities andcleaningsystems.

• Ensureprocessesareproperlydefinedandqualifiedacrossthe validationlifecycleusingarisk-basedapproach.

• Collaboratewithcross-functionalteams(Engineering Automation E&HSQuality) andexternalpartnersto driveprojectexecution.

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

• Managedeviationsincludingtroubleshooting 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(Masterspreferred)with810yearsofexperiencein CQV/validationwithinregulatedenvironments.

• Strong expertise in qualification and validation ofequipment utilities andfacilitiesapplyingscience- andrisk-basedapproaches.

• Provenexperienceauthoringandreviewingvalidation documentationwithsolidknowledgeofqualityriskmanagement 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-solvingcriticalthinking and attention todetailwiththeabilitytomanageprioritiesin a fast-pacedenvironment.

• Effectivecommunicatorin English (Frenchisa plus) able toworkbothindependentlyandcollaborativelyacrossmultidisciplinaryteams.

WhySandoz

GenericandBiosimilarmedicinesare the backbone of the globalmedicinesindustry. Sandoz a leader in thissectorprovidedmore than900 million patienttreatmentsacross100 countries in 2024andwhilewe areproudof thisachievement wehave an ambition todomore!

Withinvestmentsin newdevelopmentcapabilities state-of-the-art production sites new acquisitions and partnerships we have theopportunitytoshapethe future of Sandoz and help more patients gainaccessto low-cost high-qualitymedicinessustainably.

Ourmomentumand entrepreneurial spiritispoweredby an open collaborative culturedrivenby ourtalentedandambitiouscolleagueswho in return forapplyingtheirskillsexperiencean agile andcollegiateenvironmentwithimpactful flexible-hybridcareerswherediversityiswelcomedandwherepersonalgrowthisencouraged!

The futureisours toshape!