Senior Equipment 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

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 tasks autonomously with minimum supervision required on day-to-day activities;
• Lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors;
• 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;
• 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 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;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.