Validation Process Engineer

Validation Process Engineer

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The Validation Process Engineer supports both clinical and commercial operations including capital requests, equipment procurement/onboarding/retirement, process/equipment qualification, monitoring and optimizing process/equipment using lean six sigma methodologies.  Authors and executes equipment/process/computer/facility validation reports and protocols.  Performs periodic reviews, re-qualifications, and data integrity assessments/remediations.

This is a full-time, on-site salary position.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role

• Develop user requirement specifications for new equipment, identify equipment vendors, procure equipment, oversee build, and ensure that equipment meets functional requirements
• Submit capital requests and manage project budget/timelines to completion
• Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed
• Author procedures and work instructions for equipment operation
• Coordinate and train operations and maintenance personnel
• Participate in Gemba Walks, Kaizens, Lean Six Sigma, site safety team initiatives and other continuous improvement projects/initiatives
• Lead and/or provide technical support for management of change forms (MOCs), deviations, change controls, CAPAs and audit findings
• All other duties as assigned

The Candidate:

• Bachelor's degree in Engineering or relevant Science field is required
• At least two years of GMP process, equipment and/or facility engineering validation experience is preferred
• Client facing project management experience is strongly preferred
• Write and execute technical documents/validation protocols
• Clear understanding of related SOPs and cGMPs and as necessary to accomplish daily tasks.
• Understands basic machine functionality (e.g. PLC’s, servo motors, controls, pneumatic function)
• Ability to read electrical schematics and mechanical drawings
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• 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 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately