Validation Process Engineer

13 hours ago


Kansas City, Missouri, United States Catalent Inc Full time
Job Title: Validation Process Engineer

Catalent Pharma Solutions is seeking a highly skilled Validation Process Engineer to join our team in Kansas City, MO. As a key member of our engineering team, you 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 and project management tools.

Key Responsibilities:
  • Develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, and oversee build to ensure that equipment meets functional requirements.
  • Submit capital requests and manage project budget/timelines to completion.
  • Prepare and execute Validation Plans, System Impact Assessments, Requirements Specifications, Design Specifications, Functional Requirements Specification, Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification for equipment and critical systems and utilities.
  • Author Procedures and Work Instructions for equipment operation, coordinate and train operations and maintenance personnel.
  • Identify and capture equipment key performance indicators from equipment and qualified equipment parameters and settings while mitigating impact on change-over cycle times.
  • Perform risk assessments for safety hazards on all equipment and work with EH&S personnel to design appropriate mitigation of hazards.
  • Understand process flow, help identify bottlenecks, support GEMBA walks, and efficiency improvements, and work with appropriate parties to provide corrective and preventive actions based on sound engineering analysis.
  • Provide technical support for deviations and CAPAs and audits.
Requirements:
  • Required: Bachelor's Degree in Engineering or Life Sciences.
  • Preferred: 2+ years of experience with GMP equipment onboarding/validation/modification.
  • Good communication and problem-solving skills highly desired.
  • Working Computer knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required.
  • Ability to work well with people of diverse cultures preferred.
Why Catalent:
  • Defined career path and annual performance review and feedback process.
  • Diverse, inclusive culture.
  • 152 hours of PTO + 8 paid holidays.
  • Several Employee Resource Groups focusing on D&I.
  • Dynamic, fast-paced work environment.
  • Positive working environment focusing on continually improving processes to remain innovative.
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
  • Competitive salary.
  • Community engagement and green initiatives.
  • Generous 401K match and Paid Time Off accrual.
  • Medical, dental, and vision benefits effective day one of employment.
  • Tuition Reimbursement.
  • WellHub program to promote overall physical wellness.
  • Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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