Senior Engineering Technician
The Senior Engineering Technician will be responsible for the overall facilities including executing the 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 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.
Shift: Day Shift - 6am-6pm Thursday - Saturday and every other Wednesday
Location: Harmans, MD - BWI
100% Onsite
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
The Candidate:- High School Diploma required; Associates/Bachelors degree preferred.
- A minimum of 5 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.
- Automation and controls operation, repairs and maintenance are preferred.
- 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.
The anticipated hourly rate for this position in Maryland is $38.46 - $52.88 plus shift differential and annual bonus, when eligible. The final hourly rate 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 states.
