Group Leader, Calibration & Maintenance, BioAnalytics

Group Leader, Calibration & Maintenance, BioAnalytics

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 Clinical Delivery Services and Biologics Analytical 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 (KCM) is hiring a Group Leader, Calibration & Maintenance, BioAnalytics. The Group Leader, BioAnalytics Calibration and Maintenance is primarily responsible for managing and coordinating all required calibration, preventative maintenance (PM) and coordinating all required maintenance work for the KCM BioAnalytics division.  This role has leadership requirements for direct reports (setting goals and expectations, reviews, and development opportunities for team members), helping to maintain the computerized maintenance management system (CMMS), managing the service request/work order process, coordinating calibration and PM work with the analytical labs, assisting in calibration tasks, and other tasks as required. This individual will be helping to maintain and remodel existing facilities, coordinate capital projects, enter service requests into our maintenance software and convert them into work orders, as well as other tasks as required.

This is a full-time on-site salaried position: Monday – Friday on day shift.

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: 

• Own the BioAnalytics calibration program by managing and coordinating all PM activities associated with new/existing equipment and lab spaces including supervision of associates performing Preventative Maintenance and Calibration work for the Biologics department. Support development of asset management according to equipment life cycle
• Maintaining the spare parts, quantity, and re-order parts for Calibration and PM interests. Performs Maintenance Approver role on department TrackWise records and Computer System Validation (CSV) reviews Support deviation investigation and change control work for PM and calibration action items in TrackWise as required. Schedule PM and Calibration efforts for laboratory equipment in conjunction with Biologics division leadership
• Support and help drive new CMMS implementation: including data migration, determining and establishing events, measurement data templates, workflows, standardizing equipment list and hierarchy, and supporting validation activities. Developing and maintaining site SOPs for the CMMS and training personnel on the proper use of CMMS. CMMS Administrative support for new/modified/retired equipment, equipment calibrations, and work order management (emergencies & PM)
• Functioning as the CMMS subject matter expert for the site including extracting data from the CMMS as needed, aligning with Global Engineering best practices for CMMS, and maintain the site’s CMMS users (active/new/modified/deactivated). Liaison with CMMS vendor (Blue Mountain or other) as well as site departments (Engineering, Operations, Validation, and Quality) on technical and support issues
• Conduct communication with vendors and schedule visits as required by coordinating with SME as well as effectively managing vendors/contractors when they are on-site. Maintain the history and schedule of calibration of equipment and standards. Manage the shipping and receiving of standards, testing units, equipment, and other hardware that may require maintenance or re-calibration
• Will