Equipment Process Engineer

Equipment Process Engineer

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

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 Equipment Engineer is responsible for aspects of introducing a new suite of biopharmaceutical products at our development and manufacturing sites. The majority of process will be liquid formulations manufactured under single-use production concept, in cleanroom environment. This role is involved in onboarding new process equipment, working closely on the ground with production and development personnel, preparing and executing commissioning and qualification protocols, organizing the production process equipment layout, and coordinating with other departments to ensure the validated status of process equipment. The project will require a full-time engineer and is a tremendous opportunity for an ambitious hands-on engineer to become a core team player in a team working for an expanding CDMO. All work to be carried out in compliance with cGMP and company standard operating procedures and policies.

This is a full-time, salaried role.  This is on site. The core hours are Monday – Friday 8:00AM – 4:30PM

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;
• Hands-on work troubleshooting and repairing bioprocess equipment. Equipment includes fermenters, bioreactors, centrifuges, 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 Quality Systems to implement equipment, facility, and automation change control, document revisions, and conduct equipment/system/instrumentation failure investigations;
• Work within manual and electronic Facilities Engineering documentation systems to maintain engineering drawings and equipment history files;
• Lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors;
• Work in mechanical rooms on utility systems (high purity water, boilers, chillers, HVAC, compressed air, specialty gases);
• Will be a company SME on bioprocess equipment across all operating departments (process development, manufacturing, testing/Quality Control);
• Work closely with facilities mechanics to minimize equipment down times, expedite preventive maintenance (PM) schedules;
• All other duties as assigned;

The Candidate

• Bachelor of Science in Engineering, Chemical or Mechanical Engineering with 1+ years related work experience (GMP / Bio-Pharma maintenance/ engineering) required;
• Demonstrated abilities in mechanical/electrical design, repairs and maintenance;
• Understand and apply engineering principles to troubleshooting and repairing bioprocess equipment and instrumentation;
• Demonstrate use of problem solving and continuous improvement techniques;
• Knowledge of documentation practices associated cGMP operations (SOPs, batch records, calibration and maintenance records, equipment logbooks, change control, etc.;
• Knowledge of biopharmaceutical equipment design, construction, operation, qualification, and maintenance;
• Knowledge of Metrology, instrumentation calibration practices, equipment process controls,