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Principal Engineer - Equipment - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/06/2025
Principal Engineer, Equipment 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 a Principal 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, coordinating with other departments to ensure the validated status of process equipment, and engineering system creation. The project will require a full-time engineer and is a tremendous opportunity for an ambitious hands-on engineer to lead the team from a technical standpoint for an expanding team in an 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 Monday - Friday 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 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 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;
- All other duties as assigned;The Candidate
- Bachelor of Science in Engineering required (Chemical or mechanical engineering preferred);
- 10+ years related work experience required (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 injectable products manufactured by aseptic processing;
- 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;
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;The Pay
- The anticipated salary range for this position in Maryland is $135,000 to $180,000.-- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other statesWhy you should join Catalent:
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