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Validation Process Engineer
1 month ago
Catalent Pharma Solutions is seeking a highly skilled Validation Process Engineer to join our team in Kansas City, MO.
Job Summary:The Validation Process Engineer will be responsible for supporting the identification and onboarding of equipment for both clinical and commercial operations, as well as optimizing processes and equipment using lean six sigma tools. This role will also involve authoring protocols and reports, managing the execution of equipment validation, and performing periodic validation reviews and re-validation activities.
Key Responsibilities:- Develop User Requirement Specifications for new equipment and identify equipment vendors
- Procure equipment, oversee build, and ensure that equipment meets functional requirements
- Submit capital requests and manage project budget/timelines to completion
- Prepare and execute Validation Plans, System Impact Assessments, and other validation-related documents
- Design and execute Performance Verification and Engineering Studies
- Author Procedures and Work Instructions for equipment operation and coordinate training for operations and maintenance personnel
- Identify and capture equipment key performance indicators and mitigate impact on change-over cycle times
- Perform risk assessments for safety hazards and work with EH&S personnel to design appropriate mitigation
- Understand process flow, identify bottlenecks, and support GEMBA walks and efficiency improvements
- Bachelor's Degree in Engineering or Life Sciences
- 2+ years of experience with GMP equipment onboarding/validation/modification
- Good communication and problem-solving skills
- Working knowledge of Microsoft Outlook, Word, Excel, and Internet Explorer
Catalent offers a dynamic and fast-paced work environment, a diverse and inclusive culture, and opportunities for career growth and development. We are committed to excellence in quality and compliance and to the safety of every patient, consumer, and employee.
Catalent is an Equal Opportunity Employer and welcomes applications from diverse candidates. If you require reasonable accommodation for any part of the application or hiring process, please contact us at .