Facilities Technical Lead

Facilities Technical Lead

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.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging.  Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.  Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia is hiring a Facilities Technical Lead. The Facilities Technical Lead. Responsible for Administrative and Clerical duties for the Technical Department, to ensure the upkeep, maintenance Capital Assets Maintenance (CAM) system and documentation that supports the operation of the site. Responsible for the documentation of Preventative, Predictive and Corrective Maintenance for 10381 Decatur, 3031 RLR and 10360 Drummond Facilities. Supports Environmental Health and Safety (EHS) administration as deemed applicable. Maintenance on Buildings (lights, doors, walls, etc.) is performed correctly and according to established procedures. 

This is a full-time role position: Monday-Friday: 8:00am-4:30pm shift. Onsite

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  

• Performs all work in accordance to company policies, procedures and regulations contained in company GMP’s, safety standards, and SOP’s. Demonstrates competency in plant safety and EHS programs as deemed applicable
• Maintain and report CMMS metrics in order to identify and drive further process improvements. Utilizes Calibration Maintenance Management Systems (CMMS) software to track maintenance activities and resource utilization within the facility and mechanical team
• Initiates, plans and schedules equipment calibrations, preventive, predictive and corrective maintenance tasks and events. Interfaces with production to obtain documentation of predictive and corrective maintenance and calibrations
• Ensures thorough follow-up with facility or mechanical staff that calibrations, PM’s and unscheduled work orders are completed in a timely fashion. Files hard copy maintenance records and related critical documentation. Performs periodic adding and revising Equipment Calibration, OM Equipment and facility schedules and tasks in CMMS
• Maintains Calibration, Mechanical Services and Facilities databases. Ensures equipment is in proper status (active, inactive, retired and missing) and all associated SOPS are followed
• Contact outside contractors to coordinate and schedule calibrations of all equipment used in the clinical facility, i.e. Calipers, scales, weights, micrometers and test targets (linear measurements). Issue/Maintain CLN# tags for new equipment after checking OM equipment entry form for completeness, data entry, content and signatures.
• Works with Quality Assurance in the event of equipment failures, investigations, change controls and audit observations. Capable of providing requested documentation and answering questions during internal and external audits related to calibrations, p