Process Engineer

Catalent•Kansas City, MO

20h•Onsite

About The Position

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary We have an opportunity for a Process Engineer to join our team. In this role, you will support both clinical and commercial operations, including capital requests, equipment onboarding and qualification, and process optimization using lean six sigma or equivalent methods. You will manage projects, monitor processes, and ensure compliance with quality and safety standards. This position reports to the Process Engineering Manager and plays a key role in driving efficiency and continuous improvement. Shift: 2nd shift Monday - Thursday, 1:30pm - 12:00am Location: Kansas City, MO 100% Onsite The Role Support daily manufacturing operations by ensuring safety, quality, delivery, and cost objectives are met. Assist with the development of User Requirement Specifications (URS) for new and modified equipment and processes. Execute small to medium capital projects, including planning, budgeting, purchasing, installation, commissioning, and project closeout. Develop and execute equipment qualification protocols (IQ/OQ/PQ) to support new equipment installations and process improvements. Author and maintain SOPs, work instructions, and equipment documentation to ensure compliant and efficient operations. Analyze manufacturing processes to identify bottlenecks, troubleshoot issues, and implement process improvements that increase efficiency and reliability. Support integration of new and modified equipment into preventive and Total Productive Maintenance (TPM) programs. Collaborate with Operations, Maintenance, Quality, and Validation teams to provide technical support for deviations, CAPAs, change controls, and continuous improvement initiatives. Participate in equipment risk assessments, Gemba walks, and safety reviews to identify hazards and support corrective actions. Coordinate equipment training, assist with capital expenditure forecasting, and work with vendors to evaluate, procure, and implement equipment and process solutions. Perform other duties as assigned.

Requirements

Bachelor’s Degree in Engineering or relevant science required.
1+ years of experience in the pharmaceutical or related manufacturing industry.
Ability to understand Standard Operating Procedures and current Good Manufacturing Practices as necessary to accomplish daily tasks.
Understanding of manufacturing equipment and controls, including programmable logic controllers (PLCs), servo motors, control systems, and pneumatics.
Strong verbal and written communication skills with the ability to interact effectively with internal and external stakeholders.
Demonstrated active listening, problem-solving, decision-making, organizational, and prioritization skills in a fast-paced environment.
Collaborative team player with a flexible, adaptable approach and the ability to work cooperatively across functional groups.

Nice To Haves

Bachelor’s Degree in Chemical Engineering or Mechanical Engineering.

Responsibilities

Support daily manufacturing operations by ensuring safety, quality, delivery, and cost objectives are met.
Assist with the development of User Requirement Specifications (URS) for new and modified equipment and processes.
Execute small to medium capital projects, including planning, budgeting, purchasing, installation, commissioning, and project closeout.
Develop and execute equipment qualification protocols (IQ/OQ/PQ) to support new equipment installations and process improvements.
Author and maintain SOPs, work instructions, and equipment documentation to ensure compliant and efficient operations.
Analyze manufacturing processes to identify bottlenecks, troubleshoot issues, and implement process improvements that increase efficiency and reliability.
Support integration of new and modified equipment into preventive and Total Productive Maintenance (TPM) programs.
Collaborate with Operations, Maintenance, Quality, and Validation teams to provide technical support for deviations, CAPAs, change controls, and continuous improvement initiatives.
Participate in equipment risk assessments, Gemba walks, and safety reviews to identify hazards and support corrective actions.
Coordinate equipment training, assist with capital expenditure forecasting, and work with vendors to evaluate, procure, and implement equipment and process solutions.
Perform other duties as assigned.