CQV Engineer

T** itre 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?

GenericandBiosimilarmedicinesare the backbone of the globalmedicinesindustry. Sandoz, a leader in thissector,providedmorethan900 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-qualitymedicines,sustainably.

Ourmomentumand entrepreneurial spiritispoweredby an open, collaborative culturedrivenby ourtalentedandambitiouscolleagues,who, in return forapplyingtheirskillsexperiencean agile andcollegiateenvironmentwithimpactful, flexible-hybridcareers,wherediversityiswelcomedandwherepersonalgrowthisencouraged!

The futureisours toshape!

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.