Référent Nettoyage TSMS H​/F

Cleaning TS/MS Referent

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!

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.

• 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.

• 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.

• 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.

Location:

Huningue, France.