Engineering Technician

Catalent Pharma Solutions•Baltimore, MD

32d•Onsite

About The Position

Engineering Technician Position Summary: Work Schedule: 6am-6pm Sunday-Tuesday and every other Wednesday 100% on-site Catalent is a leading global CDMO, partnering with pharmaceutical, biotech, and self-care companies to accelerate the development, manufacturing, and delivery of life-changing therapies, and our Gene Therapy facility at the University of Maryland (UMD) BioPark in Baltimore, MD specializes in upstream and downstream viral vector process development for clinical programs, with advanced development labs and cGMP cleanroom suites supporting Phase 1 and 2 programs across AAV, vaccines, and oncolytic immunotherapies within a highly collaborative biotech and research hub. We are currently seeking an Engineering Technician to provide technical support to GMP manufacturing/testing operations for Phase I/II bulk, Phase III and finished biologics in our multi-product facility in Maryland. The Engineering Technician will be responsible for the overall facilities including executing the preventative maintenance, repairs, and installation of process equipment. The Engineering Technician will report to the Supervisor, Engineering Technician. 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. Will 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. Will be 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

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 (e.g. Word and Excel).
Must be able to clearly communicate (verbal, written).
Must have the ability to lift/carry 40 lbs.
Must have the ability to work on ladders/step stools.
Requires working extended periods on his/her feet in a manufacturing environment.
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

Provide technical support to GMP manufacturing/testing operations for Phase I/II bulk, Phase III and finished biologics.
Execute preventative maintenance, repairs, and installation of process equipment.
Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for manufacturing equipment/systems and instrumentation.
Troubleshoot and repair bioprocess equipment including fermenters, bioreactors, centrifuges, tangential flow filtration systems, chromatography systems, incubators, BSCs, controlled temperature units, and laboratory equipment.
Complete preventive and responsive maintenance work orders within a Computerized Maintenance Management System (CMMS).
Maintain engineering drawings and equipment history files within manual and electronic engineering documentation systems.
Work with subcontractors and vendors on equipment preventive maintenance, calibrations, and repairs.
Assist in maintaining PM programs for bioprocess equipment and instrumentation, including generating PM SOPs/records, establishing PM frequencies, specifying spare parts, and recommending/maintaining inventory levels.
Quote/purchase/procure equipment parts and instrumentation with equipment vendors and Catalent’s purchasing department.
Develop job aids, work instructions, and troubleshooting guides for performing routine maintenance and repairs.
Generate and update documentation throughout the life cycle of the equipment.
Work in cleanrooms requiring full gowning.