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
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.
