Engineering Technician

Engineering Technician

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 Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

Catalent Pharma Solutions in Harmans, MD is hiring an Engineering Technician who is responsible to provide technical support to GMP manufacturing/testing operations for Phase I/II bulk, Phase III and finished biologics in our multi-product facility in Harmans, MD. The Engineering Technician will report to the Manager – Process Engineering, and will be responsible for the overall facilities including executing the preventative maintenance, repairs, and installation of process equipment.

This is a full-time on-site overnight hourly role.  The core hours for this position are 7:00PM-7:00AM Week 1 Sunday - Tuesday, Week 2 Sunday – Wednesday. 

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

• Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for manufacturing equipment/systems and instrumentation;
• Work independently on assigned projects and collaboratively in a multi-functional team environment supporting day-to-day manufacturing schedules and operations;
• Drawing upon seasoned mechanical and electrical experience, will engage in hands-on work troubleshooting and lead the repairing of bioprocess equipment. Equipment includes fermenters, bioreactors, centrifuges, tangential flow filtration systems, chromatography systems, incubators, BSCs, controlled temperature units, and laboratory equipment;
• Work within Computerized Maintenance Management Systems (CMMS) to complete preventive and responsive maintenance work orders;
• Work within manual and electronic engineering documentation systems to maintain engineering drawings and equipment history files;
• Work with subcontractors and vendors as needed on equipment preventive maintenance, calibrations, and repairs;
• Assist in maintaining PM programs for the bioprocess equipment and instrumentation.  This includes generating PM SOPs/records, establishing PM frequencies, specifying spare parts and recommending/maintaining inventory levels;
• Work with equipment vendors and Catalent’s purchasing department to quote/purchase/procure equipment parts and instrumentation;
• Develop job aids, work instructions, and troubleshooting guides for performing of routine maintenance and repairs. Will be responsible for generating and updating documentation throughout the life cycle of the equipment;
• Work in cleanrooms that requires full gowning (tyvek coverall, gloves, hair cover, shoe covers.);
• All other duties as assigned;

The Candidate

• High School Diploma required; Associates/Bachelors degree preferred;
• Three years or more of related work experience required, specifically in GMP / Bio-Pharma maintenance and/or engineering experience;
• Clean room experience or experience in a similar GMP / FDA regulated industry;
• Must demonstrate abilities in mechanical/electrical repairs and maintenance;
• Automation and controls operation, repairs and maintenance are preferred;
• Requires basic math and computer sk