Job Description

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

(English version below)

En tantqueRéférentNettoyageTS/MS, vousêtesl’experttechnique et leréférentunique de lastratégiedenettoyagedu site deHuningue Vousgarantissezl’intégrité, laconformitéetl’efficacitédes processus denettoyageafindemaintenirun étatvalidépermanent, desécuriserla production et derépondreaux exigencesréglementaires

Vousjouezégalementunrôleclédans la coordinationopérationnelle,l’améliorationcontinue etl’intégrationdes exigences denettoyagedans les nouveauxprojetsdu site.

Vosresponsabilités

• Définir,piloteret faireévoluerlastratégiedenettoyagedu siteenassurantlapropriétédu Plan Directeur de Validation duNettoyage(VMP) etengarantissantun étatvalidépermanent desprocédésdenettoyage

• Rédiger,approuveretmaintenirla documentationassociéeaunettoyage,incluantlesprotocoleset rapports de validation, les revuespériodiques, les release notifications, lediagrammede flux denettoyage(CFD) et les matrices denettoyage

• Êtrele point de contact principallorsdes audits internes et externes,notammentFDA et EMA, pourtouslessujetsliésaunettoyage, toutenassurantuneveilleréglementaireactive et le partage desmeilleurespratiques au sein du réseau Small Moleculesd’Elanco

• Organiser etcoordonnerles phasesopérationnellesdenettoyage, deprélèvementetd’écouvillonnageenlienétroitavec le planning de production,accompagnerlestechniciensde la Loop 1 sur le terrain etgarantiruneexécutionrigoureuse,homogèneetconforme

• Piloterles investigationsliéesauxdéviationsdenettoyage,évaluerl’impactdes Change Controls surl’étatvalidé,conduiredesprojetsd’optimisationvisantàréduireles temps etcoûtsdenettoyage,évaluerl’impact“nettoyage” des nouveauxproduitsetéquipementsdèsla conception, etagircommeinterlocuteurprivilégiépour lesactivitésdenettoyagedel’usinepilote

Cedontvousavezbesoinpourréussir(qualificationsminimales) :

• Diplômed’Ingénieur, MasterouPharmacienavecunespécialisationtechnique.

• Minimum 3 à 5ansd’expérienceenvalidation denettoyageouenTS/MS dans unenvironnementGMP.

• Maîtrisedesméthodesdeprélèvementswab/rinse et descalculsdelimitesderésidus; bonneconnaissancedes exigencesréglementairesinternationalesenvalidation denettoyage

• Français courant.

Ce qui vousdonneraunavantagecompétitif(qualificationspréférées) :

• Expériencede coordination transverse entre production,qualité, validation et support technique.

• Exposition aux auditsréglementairesFDA, EMAouéquivalentssur dessujetsliésaunettoyage

• Expérienceenaméliorationcontinue etenoptimisation des temps etcoûtsdenettoyage

• Connaissancedel’intégrationdes exigences denettoyagedans desprojetsnouveauxproduitsounouveauxéquipementsdansunelogiqueQuality by Design.

• Anglaisprofessionnelsouhaité

Nos plus qui font ladifférence

• 26joursde congéspayés+ 15 RTT/an (RTT àretirerpour le 5*8).

• Part variable surtouslespostes

• Intéressement& Participation.

• Épargnesalariale(PEE, PERCOL,retraitesupplémentaire) avecabondementjusqu’à3 000 €.

• Restaurantd’entreprise traiteursubventionnésoupanier.

• Remboursementtransportsencommunà 80% ;prime de transport.

• Mutuelle santé &prévoyance

• Vousrejoindrezun site de productionencroissanceetengagépour la santéanimale,éthiqueetinnovante

Localisation :
Huningue, France.

Aproposde Elanco
Groupepharmaceutiqueinternational leader dans ledéveloppementdeproduitset servicesaméliorantla santé desanimauxde compagnie et derente Ledéveloppementde Elanco estfondésur desvaleursfortes etimportantesquisontl’Intégrité, le Respect etl’Excellence Le site deHuningue,basédans le Sud Alsace, a plus de 35ansd’expérienceet de savoir-faire, il estspécialisédans la production decompriméspour lesanimauxde compagnie.
Vousvoulezrejoindreun site convivial à taille humaine avec de fortesvaleurs,offrantun cadre de travailattractif?
Vousavezenvied’intégrerunesociétéencroissancedotéed’outilsde productionmoderneset performants ?
Vousêtespassionné(e) parl’industriepharmaceutique?Ecrivez-nous !

English version

As the Cleaning TS/MS Referent, you are the technical expert and sole reference point for the site’s cleaning strategy in Huningue. You ensure the integrity, compliance, and effectiveness of cleaning processes in order to maintain a permanent validated state, secure production, and meet regulatory requirements.

You also play a key role in operational coordination, continuous improvement, and the integration of cleaning requirements into new site projects.

Your responsibilities

• Define, lead, and evolve the site cleaning strategy by owning the Cleaning Validation Master Plan (VMP) and ensuring a permanent validated state for cleaning processes.

• Write, approve, and maintain all cleaning-related documentation, including validation protocols and reports, periodic reviews, release notifications, the Cleaning Flow Diagram (CFD), and cleaning matrices.

• Act as the main point of contact during internal and external audits, including FDA and EMA audits, for all cleaning-related topics, while maintaining active regulatory watch and sharing best practices within Elanco’s Small Molecules network.

• Organize and coordinate operational cleaning, sampling, and swabbing phases in close alignment with the production schedule; support Loop 1 technicians in the field; and ensure rigorous, consistent, and compliant execution.

• Lead investigations related to cleaning deviations, assess the impact of Change Controls on the validated state, drive optimization projects aimed at reducing cleaning time and cost, assess the cleaning impact of new products and equipment early in the design phase, and act as the preferred contact for pilot plant cleaning activities.

What you need to succeed — minimum qualifications

• Engineering degree, Master’s degree, or Pharmacy degree with a technical specialization.

• At least 3 to 5 years of experience in cleaning validation or TS/MS in a GMP environment.

• Strong command of swab/rinse sampling methods and residue limit calculations; solid knowledge of international regulatory requirements for cleaning validation.

• Fluent French.

What will give you a competitive edge — preferred qualifications

• Experience working cross-functionally across production, quality, validation, and technical support.

• Exposure to regulatory audits such as FDA, EMA, or equivalent on cleaning-related topics.

• Experience in continuous improvement and in optimizing cleaning time and cost.

• Knowledge of integrating cleaning requirements into new product or new equipment projects within a Quality by Design mindset.

• Professional English preferred.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.