Senior Engineer - Engineering, Equipment

Catalent•Madison, WI

2d•Onsite

About The Position

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. The Senior Engineer, Equipment supports process, equipment, or automation engineering activities by troubleshooting complex issues, leading technical projects, and driving continuous improvement in a GMP biologics manufacturing environment. The role partners cross-functionally and provides on-the-floor technical support while leading projects, managing data analysis, and interacting with clients.

Requirements

Bachelor’s degree in Engineering or related scientific field with 6–9 years of experience, OR Master’s degree with 4–6 years of experience, OR PhD with 0–2 years of experience
Strong technical knowledge and hands-on experience in GMP biologics manufacturing and validation
Experience with deviations, CAPAs, change control, and risk assessments
Ability to analyze data, troubleshoot issues, and drive corrective actions
Experience authoring technical documentation such as SOPs, batch records, and reports
Strong communication skills and ability to work cross-functionally and with clients

Responsibilities

Support engineering activities including troubleshooting mechanical/process issues and identifying improvements to minimize downtime and reduce cost
Provide on-call and on-the-floor technical support to manufacturing operations
Develop and execute technical work plans and ensure projects meet scope, schedule, and performance metrics
Work cross-functionally with Operations, MS&T, Quality, Supply Chain, and other departments to support manufacturing processes
Lead or support deviation investigations, change controls, CAPAs, and risk assessments
Compile and analyze process data, identify trends, and communicate project status to internal and client stakeholders
Author and review technical documentation (batch records, protocols, reports, specifications)
Participate in client meetings and provide technical leadership across projects and disciplines