Engineering Technician

Catalent•Harmans, MD

4d•Onsite

About The Position

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. Position Summary: The Engineering Technician provides technical support for GMP manufacturing and testing operations supporting Phase I/II bulk production, Phase III clinical manufacturing, and commercial biologics within a multi-product facility. This role is responsible for maintaining facility and process equipment reliability through the execution of preventive maintenance programs, troubleshooting and repairs, and installation of manufacturing equipment. The Engineering Technician works closely with cross-functional teams to ensure equipment performance, operational efficiency, and compliance with GMP requirements, and reports directly to the Supervisor, Engineering Technician.

Requirements

High School Diploma required
A minimum of 3 years of related work experience, 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.
Requires basic math and computer skills (eg. Word and Excel) and must be able to clearly communicate (verbal, written).
Must have the ability to lift/carry 40 lbs. and to work on ladders/step stools.
Requires working extended periods on his/her feet in a manufacturing environment and must follow all Catalent’s Safety and Quality procedures and practices.

Nice To Haves

Associates/Bachelors degree preferred.
Automation and controls operation, repairs and maintenance are preferred.

Responsibilities

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.
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 routine maintenance and repairs.
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.)
Other duties as assigned