Process Engineer
18 hours ago
Catalent is seeking a highly skilled Process Engineer to join our team in Kansas City, MO. As a Process Engineer, you will play a critical role in supporting both clinical and commercial operations, including capital requests, equipment onboarding/qualification, process qualification, monitoring, and optimizing process/equipment using Lean Six Sigma (or equivalent), and project management.
Key Responsibilities- Ensure Safety, Quality, Delivery, and Costs are managed to meet project requirements
- Develop User Requirement Specifications for new equipment or modification of current equipment
- Author Standard Operating Procedures and Work Instructions for equipment operation
- Successfully execute Capital projects through all phases, including developing budget and scope, authoring required documents and forms for approval, purchasing equipment, overseeing installation of equipment and modifications of facilities, commissioning of equipment, and closing out of project
- Perform Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for more advanced equipment
- Design and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for equipment onboarding/modification/optimization
- Determine process capabilities and bottlenecks and implement improvements which have direct impact on efficiency
- Facilitate inclusion of all new or modified equipment into the site Total Productive Maintenance (TPM) program
- Support the on-going enhancement and optimization of manufacturing process systems by using a cGMP change management and software development lifecycle approach
- Identify lean improvement opportunities and implement solutions to improve efficiency
- Participate in technical investigations for deviations as needed for equipment and processes. Complete corrections and actions when assigned
- Required: Bachelor's degree in Chemical, Electrical, and Mechanical Engineering or Life Sciences with One+ years of experience in the Pharmaceutical or related manufacturing industry
- Basic understanding of machine functionality (e.g. PLC's, servo motors, controls, pneumatic function highly desired)
- Possess good communication and problem-solving skills highly desired
- Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. We are committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
Catalent offers a dynamic, fast-paced work environment with opportunities for career growth on an expanding team within an organization dedicated to preserving and bettering lives. We provide a comprehensive benefits package, including 152 hours of PTO + 8 paid holidays, several Employee Resource Groups focusing on D&I, and a generous 401K match.
Join us in making a difference and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
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