Validation Engineer

Elanco; Elwood (IN); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Elanco is seeking a Quality & Validation professional to lead commissioning, qualification, and requalification activities at the Elwood manufacturing site. The role emphasizes regulatory compliance, documentation, and cross-functional collaboration with project teams.

You will perform risk assessments, develop QA documents, and support audits while ensuring state-of-the-art quality standards align with cGMP and corporate goals.

Qualifications

• Master’s degree in IT, CS, or related field, or foreign equivalent with 2 years post-bac experience.
• Regulatory knowledge across FDA, GMP, and ISO frameworks.
• Technical writing and documentation experience for clear, user-friendly materials.
• Validation protocols & methodology experience to prove systems meet specs.
• Data analysis using JMP, Ellab Suite, Aveeva PI.
• Risk assessment and FMEA knowledge and application.
• Software/automation tools including Aveeva PI, SAP, Ellab.

Responsabilités

• Coordinate commissioning, qualification, and requalification activities for facilities, equipment, and systems at the Elwood facility.
• Collaborate with system owners to define user requirements and C&Q strategies.
• Prepare, execute, and review C&Q protocols and reports compliant with cGMP.
• Identify quality issues and drive root-cause analysis and CAPAs.
• Provide technical input on facility/modifications to align with validation strategy.
• Oversee timely qualification activities and coordinate with project plans.
• Support audits and develop corrective actions as assigned.
• Contribute to budgeting and project planning for QA/QC.
• Train personnel and act as SME on quality and validation standards.
• Adhere to cGMP and safety standards and maintain training.

Connaissances

Regulatory knowledge

Technical writing

Validation protocols

Data analysis

Root cause analysis

Risk assessment

Software/automation tools

Formation

Master’s degree in IT/CS or related field + 2 years experience

Outils

Aeveva PI

Ellab Suite

JMP

SAP

Description du poste

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!

Your day-to-day will include:

• 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 serving 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.

You have the following 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.

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