CEVA SANTE ANIMALE
Overview
Ceva Animal Health is a global leader in animal health. We are committed to the health and wellbeing of farm animals, companion animals, and wildlife, and to a One Health approach. We value diversity, equity and inclusion and provide accommodations to ensure an inclusive interview process. If you need an accommodation, contact a member of the Ceva Talent Acquisition team. Role
Sterility Assurance Lead — Location: Lenexa, KS. The Sterility Assurance Lead will oversee sterility assurance processes and related documentation to ensure compliance with CGMPs and official guidelines. This role collaborates with the Quality Assurance Team and other functions within the End-to-End organization, including Focus Factory (Operations), Quality Assurance, Quality Control, and Supply Chain Support. The role also manages critical contamination investigations related to Environmental Monitoring, Sterility Testing, APS failures, and the prevention of biofilm formation. The individual will be part of the Global CEVA Aseptic Community. Responsibilities And Key Duties
Ensure the completion of 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; maintain inspection readiness and serve as a key 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 to propose corrective actions. Lead critical contamination investigations related to environmental monitoring (EM), sterility testing, APS failures, and biofilm issues to reduce non-quality batches due 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 and engage with operational teams to ensure compliance and readiness for external inspections. Collaborate with team members to ensure the campus is inspection-ready. Work with HSE and Operations to ensure safety compliance by communicating expectations, assessing behaviors, and enforcing SOPs and quality guidelines. Core Competencies
Collaborates effectively, considering others to enhance efficiency and fostering a team environment. Promotes engagement and challenges the status quo to simplify processes. Demonstrates client focus by prioritizing client needs and cross-functional teamwork. Technical / Functional Competencies
Experience in aseptic and sterile manufacturing operations with a focus on contamination control. Knowledge of GMP and regulatory requirements (USP, EMA, PIC/S). Practical expertise in pharmaceutical microbiology and ability to coach team members in these areas. Familiarity with microbiological testing technologies and methodologies. Understanding of aseptic processes, clean room protocols, environmental monitoring, qualification procedures, and disinfectant usage. Excellent interpersonal and networking skills. Qualifications
Education – BS/BA in life science or related field is required; equivalent work experience may be substituted for degree. Work Experience – 3+ years in the manufacture of biologicals or pharmaceuticals requiring aseptic processes. Strong computer skills (Word, Excel, Visio, JMP, Minitab, etc.) are preferred. Experience with MRP systems (e.g., JDE or SAP) and Quality Management System software (CQMS, Trackwise, Veeva) for managing deviations, change control, and complaints is preferred. Physical Requirements
Ability to read, write legibly and communicate in English. Visual inspection capabilities. Travel
5-10% travel, depending on business needs. Ceva reserves the right to modify job duties and/or descriptions at any time to meet business needs. Ceva is an equal opportunity employer; all qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, veteran status, or any other characteristic protected by law.
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Ceva Animal Health is a global leader in animal health. We are committed to the health and wellbeing of farm animals, companion animals, and wildlife, and to a One Health approach. We value diversity, equity and inclusion and provide accommodations to ensure an inclusive interview process. If you need an accommodation, contact a member of the Ceva Talent Acquisition team. Role
Sterility Assurance Lead — Location: Lenexa, KS. The Sterility Assurance Lead will oversee sterility assurance processes and related documentation to ensure compliance with CGMPs and official guidelines. This role collaborates with the Quality Assurance Team and other functions within the End-to-End organization, including Focus Factory (Operations), Quality Assurance, Quality Control, and Supply Chain Support. The role also manages critical contamination investigations related to Environmental Monitoring, Sterility Testing, APS failures, and the prevention of biofilm formation. The individual will be part of the Global CEVA Aseptic Community. Responsibilities And Key Duties
Ensure the completion of 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; maintain inspection readiness and serve as a key 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 to propose corrective actions. Lead critical contamination investigations related to environmental monitoring (EM), sterility testing, APS failures, and biofilm issues to reduce non-quality batches due 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 and engage with operational teams to ensure compliance and readiness for external inspections. Collaborate with team members to ensure the campus is inspection-ready. Work with HSE and Operations to ensure safety compliance by communicating expectations, assessing behaviors, and enforcing SOPs and quality guidelines. Core Competencies
Collaborates effectively, considering others to enhance efficiency and fostering a team environment. Promotes engagement and challenges the status quo to simplify processes. Demonstrates client focus by prioritizing client needs and cross-functional teamwork. Technical / Functional Competencies
Experience in aseptic and sterile manufacturing operations with a focus on contamination control. Knowledge of GMP and regulatory requirements (USP, EMA, PIC/S). Practical expertise in pharmaceutical microbiology and ability to coach team members in these areas. Familiarity with microbiological testing technologies and methodologies. Understanding of aseptic processes, clean room protocols, environmental monitoring, qualification procedures, and disinfectant usage. Excellent interpersonal and networking skills. Qualifications
Education – BS/BA in life science or related field is required; equivalent work experience may be substituted for degree. Work Experience – 3+ years in the manufacture of biologicals or pharmaceuticals requiring aseptic processes. Strong computer skills (Word, Excel, Visio, JMP, Minitab, etc.) are preferred. Experience with MRP systems (e.g., JDE or SAP) and Quality Management System software (CQMS, Trackwise, Veeva) for managing deviations, change control, and complaints is preferred. Physical Requirements
Ability to read, write legibly and communicate in English. Visual inspection capabilities. Travel
5-10% travel, depending on business needs. Ceva reserves the right to modify job duties and/or descriptions at any time to meet business needs. Ceva is an equal opportunity employer; all qualified applicants will be considered without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, veteran status, or any other characteristic protected by law.
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