Sterility Assurance Lead

Sterility Assurance Lead

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As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

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Sterility Assurance Lead

Location : Lenexa, KS

The Sterility Assurance Lead will oversee sterility assurance processes and related documentation to ensure compliance with CGQS and official guidelines. This role involves collaborating with the Quality Assurance Team and other key functions within our End-to-End organization, including Focus Factory (Operations), Quality Assurance, Quality Control, and Supply Chain Support. The role will also manage critical contamination investigations related to various areas, including Environmental Monitoring, Sterility Testing, APS failures, and the prevention of Biofilm formation. Additionally, this individual will be a part of the Global CEVA Aseptic Community.

Responsibilities and Key Duties :

• Ensure the completion of various tasks to adhere to the sterility assurance roadmap at the site.
• Manage the implementation and monitoring of the Campus Control Contamination Strategy.
• Provide quality oversight for all aspects related to sterility assurance within the manufacturing network.
• Harmonize and standardize all aseptic practices on-site.
• Participate in supervising Aseptic Process Simulation Validation.
• Act as Subject Matter Expert to the QA operations group to ensure compliance with quality standards, current Good Manufacturing Practices (cGMPs), and regulatory requirements. This includes maintaining inspection readiness and serving as a key point of contact during audits.
• Review and update the current risk assessment of sampling points in Environmental Monitoring
• Drive continuous improvement of the existing strategy.
• Manage alerts / actions and evaluate trending data and propose pertinent corrective actions.
• Lead critical contamination investigations related to environmental monitoring (EM), sterility testing, Aseptic Process Simulation (APS) failures, and biofilm issues to reduce non-quality batches linked to microbial contamination.
• Provide microbiological and aseptic training and serve as a reference for EU Annex 1 regulations.
• Conduct aseptic observations at the shop floor level.
• Perform self-inspections, including visits and observations of practices in the field, while engaging with operational teams.
• Collaborate with team members to ensure the campus is always inspection-ready and actively participate in external inspections.
• Work with HSE and Operations to ensure safety compliance by clearly communicating expectations, assessing behaviors, and enforcing SOPs and quality guidelines.

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Travel Required :

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and / or job descriptions at any time to meet the needs of the business.

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