Validation Engineer

Elanco; Elwood (KS); On-site; USD 90,000 - 130,000; Full time

Job summary

Elanco is seeking a qualified C&Q professional to coordinate commissioning, qualification, and verification activities at the Elwood, KS mAb facility, ensuring cGMP compliance and alignment with validation strategies.

You will collaborate with system owners, develop SOPs, and review protocols and reports while supporting audits and budgets. A Master’s degree and 2 years of regulatory/validation experience are required.

Qualifications

• Master’s degree in Information Technology, Computer Science, or related field and 2 years of post-baccalaureate experience in job offered or related roles.
• Regulatory knowledge across FDA, GMP, and ISO frameworks to control and improve processes.
• Technical writing and documentation to produce clear, user-friendly materials.
• Validation Protocols & Methodology to prove system/process meets specs and standards.
• Data Analysis and Statistics including JMP, Ellab Suite, Aveeva PI.
• Problem-Solving and Troubleshooting using 5 Whys, Ishikawa, Pareto charts.
• Risk Assessment (FMEA/Quality Risk Management) and associated activities.
• Software/Automation tools including Aveeva PI, SAP, and BMS.

Responsibilities

• Coordinate planning and execution of commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems at Elwood, KS.
• Collaborate with system owners to define user requirements, develop SOPs, and establish C&Q strategies.
• Prepare, execute, and review protocols and reports for C&Q and validation.
• Identify quality issues, perform root cause analyses, and manage CAPAs within the quality management system.
• Provide input on facility/equipment modifications to align with validation strategy and regulatory compliance.
• Oversee timely performance of qualification/verification activities with project plans.
• Support audits by regulatory bodies and corporate teams, developing audit responses and corrective actions.
• Contribute to budgeting and project planning; train personnel as SME on quality and validation standards.

Skills

Regulatory knowledge

Technical writing

Validation protocols

Data analysis

Problem solving

Risk assessment

Software/automation tools

Education

Master’s degree in Information Technology, Computer Science, or related field

Tools

JMP

Ellab Suite

Aveeva PI

SAP

BMS

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!

Day-to-Day Responsibilities

• Coordinate the planning and execution of commissioning, qualification, and requalification activities for facilities, utilities, equipment, and computerized systems at the Elwood, Kansas mAb manufacturing facility, ensuring adherence to Elanco and regulatory standards.
• Collaborate with system owners to define user requirements, develop detailed operating procedures, and establish strategies for commissioning and qualification (C&Q).
• Prepare, execute, and review protocols and reports for commissioning, qualification, and validation, verifying that documentation is complete, accurate, and compliant with cGMP and regulatory standards.
• Identify quality issues, manage root cause analysis, and assign corrective and preventative actions within the quality management system to ensure standards are met.
• Provide technical input on facility and equipment modifications to align with the validation strategy and ensure regulatory compliance.
• Oversee the timely performance of qualification and verification activities, coordinating with project and validation master plans.
• Support compliance during audits by regulatory bodies and corporate teams, developing audit responses, and completing corrective actions as assigned.
• Contribute to departmental and project budgeting, maintaining alignment with project requirements.
• Train personnel and serve as a subject matter expert on quality and validation standards, promoting C&Q knowledge across the site.
• Adhere strictly to cGMP standards, promoting a "Safety First and Quality Always" approach, and completing required training to stay current with industry standards.
• Provide C&Q support to project teams, focusing on local and major capital projects from planning through to qualification.
• Participate in all phases of capital project activities, including scope definition, design option analysis, user requirement specification, equipment selection, and C&Q execution.
• Act as a C&Q subject matter expert on project teams and relevant committees.
• Create, review, and update C&Q documentation, including user requirements, C&Q plans, and protocols, to ensure consistency with project and quality objectives.
• Prepare change management plans and follow through with associated action items to maintain continuous improvement and quality control.

Technical Skills and Qualifications

Requirement – Master’s degree in Information Technology, Computer Science, a related field, or a foreign equivalent plus 2 years of post-baccalaureate experience in job offered or any engineering related roles. Relevant experience – Applicants must have 2 years of experience in the following: (1) Regulatory knowledge and compliance across the FDA, GMP, and ISO frameworks to systematically control, document, and continuously improve processes that produce safe, highly reliable products that consistently meet both strict legal mandates and international quality standards; (2) Technical writing and documentation to produce specialized information into clear, accurate, and user-friendly materials, enabling readers to efficiently complete tasks, operate products, or understand systems; (3) Validation Protocols & Methodology to provide the structured framework and documented methodology used to scientifically prove that a system, process, or analytical method consistently meets predetermined specifications, regulatory standards, and intended performance requirements; (4) Data Analysis and Statistics including JMP, Ellab Suite, Aveeva PI; (5) Problem-Solving and Troubleshooting including Root cause analysis tools; 5 Whys, Ishikawa Diagrams, and Pareto Charts; (6) Risk Assessment (FMEA/Quality Risk Management) including facilitating and contribute to the creation of risk assessments and FMEAs as necessary site systems; and (7) Software/Automation Tools including Aveeva PI, site BMS, Ellab Suite, and SAP.

EEO Statement

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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.