Senior Process Engineer

Senior 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 a Senior Engineer, Equipment who 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 a 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 onsite.  The core hours are 8:00AM – 5:00PM

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, instrumentation, and filling equipment;
• 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, fillers, isolators and laboratory equipment;
• Hands-on work with Fill/finish process scale-up and technology transfer including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.);
• Work within Computerized Maintenance Management Systems (CMMS) to complete This position requires a professional who will be expected to perform tasks autonomously at times; minimum supervision required on day-to-day activities and accomplished tasks;
• Will be required at times to lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors;
• Supervisory input focused on status and future of project or technical area and long-term development path;
• 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;
• All other duties as assigned;

The Candidate

• Bachelor of Science in Engineering, chemical or mechanical engineering required with 4+ years related work experience (GMP / Bio-Pharma maintenance/ engineering).
• Demonstrated abilities in mechanical/electrical design, repairs and maintenance;
• Understand and apply engineering principles to troubleshooting and repairing bioprocess equipment and instrumentation;
• Experience with filling of drug product and familiarity with aseptic filling equipment including isolator technology;
• Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injecta