Validation Process Engineer

Disability Solutions - Kansas City, MO

Full-time - Entry Level

Kansas City, MO

About the position

The Validation Process Engineer at Catalent PharmaSolutions in Kansas City, MO, plays a crucial role in supporting the identification and onboarding of equipment for clinical and commercial operations. This position focuses on optimizing processes and equipment using lean six sigma methodologies, project management, and change management tools. The engineer is responsible for authoring protocols and reports, managing the execution of various validations, and performing periodic reviews and re-validations to ensure compliance and efficiency in operations.

Responsibilities

• Develop User Requirement Specifications for new equipment.
• Identify equipment vendors and procure equipment.
• Oversee equipment build and ensure it meets functional requirements.
• Submit capital requests and manage project budget/timelines to completion.
• Prepare, execute, and review Validation Plans (VP) and other validation documents.
• Design and execute Performance Verification (PV) and Engineering Studies (ES).
• Support Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for equipment.
• Author Procedures and Work Instructions for equipment operation.
• Coordinate and train operations and maintenance personnel.
• Perform risk assessments for safety hazards on all equipment.

Requirements

• 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.

Nice-to-haves

• Ability to work well with people of diverse cultures.
• Experience in a fast-paced work environment.

Benefits

• Defined career path and annual performance review.
• 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 continual improvement.
• Potential for career growth.
• Competitive salary.
• Community engagement and green initiatives.
• Generous 401K match.
• Medical, dental, and vision benefits effective day one.
• Tuition Reimbursement.
• WellHub program to promote overall physical wellness.
• Exclusive discounts from approximately 900+ merchants.