Job Information
Cardinal Health Validation Engineer in Gananoque, Canada
Cardinal Health Canada is currently seeking a Validation Engineer to join the Engineering department on a full time, permanent basis in our Medical Device Manufacturing Facility in Gananoque, Ontario.
For more information on what it is like to work for us, please watch this video: Cardinal Health - Wings (https://www.youtube.com/watch?v=zA4HVn5g5DI) .
Under the supervision of the Engineering Manager, the Validation Engineer is responsible for ensuring compliance to procedures and processes that meet the required ISO standards. The Validation Engineer will provide process and project leadership, support and direction for both existing operations and for future needs to improve process capability, foster growth, reduce manufacturing costs and deliver step change improvements to both process and product attributes.
The incumbent will be required to apply knowledge of engineering principles and practices to effectively accomplish technical assignments and projects supporting an FDA regulated 24/7 manufacturing environment.
Major Responsibilities :
Regulatory Compliance
Be a champion of change in alignment with corporate change control procedures and stringent validation requirements.
Develop, execute and document protocols and reports for test methods, process studies and process validations.
Maintain accurate and compliant documentation to meet company and regulatory expectations.
Maintain master validation log for tracking and master validation reports for audit preparedness.
Ensure that all validation activities comply with relevant regulatory standards, such as FDA regulations, Good Manufacturing Practices (GMP), and ISO requirements.
Support for manufacturing issues, CAPA’s, SCARS and audits.
Write and/or update all documentation used on the production floor in the manufacturing of product, including process, general and lab procedures.
Process Optimization
Drive process improvements for existing manufacturing products and processes, process development for new products and root cause understanding for production issues.
Apply statistical methods including DOE, SPC, Flow Charting, and FMEA tools as part of routine process analysis.
Provide input and support for new product process concepts and implement technology advancements and best practices into operations.
Proactively identify opportunities for process optimization, efficiency improvements, and risk mitigation within the validation processes and recommend appropriate corrective actions.
Education & Experience:
Bachelor's Degree in Engineering required (Electrical, Controls, Mechanical, Manufacturing, Chemical)
3 - 5 years’ manufacturing experience
Word, Excel, PowerPoint, Project, Access, Minitab, AutoCAD/Solid Edge required.
Knowledge of Lean and Six Sigma tools and implementation techniques preferred.
Eligible for membership in PEO.
Working knowledge of quality system regulations, GMPs and ISO preferred.
Knowledge of OHSA/WHIMIS Safety requirements preferred.
Ability to lead and facilitate teams.
Ability to prioritize tasks and work in a fast-paced, changing environment.
Solid trouble shooting skills.
Ability to identify root cause and implement long term solutions.
Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Aboriginal peoples and persons with disabilities.
Cardinal Health is committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Our Human Resources team is responsible for working with applicants requesting accommodation at any stage of the hiring process.
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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