Senior Engineering Technician
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus, featuring two manufacturing facilities approximately 5 miles from Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus supports Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
About the role
The Senior Engineering Technician will be responsible for overall facilities maintenance, including executing preventative maintenance, repairs, and installation of process equipment supporting Phase I/II bulk production, Phase III clinical manufacturing, and commercial biologics within a multi-product facility. This role ensures facility and process equipment reliability through preventive maintenance programs, troubleshooting, repairs, and equipment installation, working closely with cross-functional teams to maintain equipment performance, operational efficiency, and GMP compliance.
Responsibilities
- Analyze and develop engineering solutions for 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 to support day-to-day manufacturing schedules and operations.
- Engage in hands-on troubleshooting and lead repairs of bioprocess equipment, including 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.
- Maintain engineering drawings and equipment history files using manual and electronic documentation systems.
- Coordinate with subcontractors and vendors for 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.
- Collaborate with equipment vendors and Catalent’s purchasing department to quote, purchase, and procure equipment parts and instrumentation.
- Develop job aids, work instructions, and troubleshooting guides for routine maintenance and repairs, and update documentation throughout the equipment lifecycle.
- Work in cleanrooms requiring full gowning (Tyvek coverall, gloves, hair cover, shoe covers).
- Perform other duties as assigned.
Requirements
- High School Diploma required; Associate’s or Bachelor’s degree preferred.
- Minimum of 5 years of related work experience in GMP/Bio-Pharma maintenance and/or engineering; cleanroom experience or experience in a similar GMP/FDA-regulated industry.
- Demonstrated abilities in mechanical/electrical repairs and maintenance; automation and controls experience preferred.
- Basic math and computer skills (e.g., Word, Excel) with clear verbal and written communication abilities.
- Ability to lift/carry 40 lbs. and work on ladders/step stools.
- Capable of working extended periods on feet in a manufacturing environment while adhering to all safety and quality procedures.
Pay
The anticipated hourly rate for this position in Maryland is $38.46 - $52.88 plus shift differential and annual bonus, when eligible. The final rate may vary based on experience, industry background, skillset, education, and business needs.
Schedule
Day Shift - 6:00 AM to 6:00 PM, Thursday through Saturday and every other Wednesday. This is a 100% onsite role located in Harmans, MD (BWI).
Benefits
Catalent offers rewarding opportunities to advance your career in a global drug development and delivery organization. Employees contribute to life-saving and life-enhancing products, producing over 70 billion doses annually. Catalent supports the development of new medicines from early-stage through clinical trials and commercialization.