Engineering Technician

Position Summary

Work Schedule: 6am-6pm Sunday-Tuesday and every other Wednesday. 100% on-site. Provide technical support to GMP manufacturing/testing operations for Phase I/II bulk, Phase III and finished biologics in a multi-product facility in Maryland. Responsible for overall facilities including executing preventative maintenance, repairs, and installation of process equipment. Reports 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.
• Engage in hands-on work troubleshooting and lead the repairing 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.
• Work within manual and electronic engineering documentation systems to maintain engineering drawings and equipment history files.
• 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.
• Work with equipment vendors and purchasing department to quote/purchase/procure equipment parts and instrumentation.
• 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 (tyvek coverall, gloves, hair cover, shoe covers).
• Other duties as assigned.

The Candidate

• High School Diploma required; Associates/Bachelors degree preferred.
• 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.
• 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 feet in a manufacturing environment and must follow all Safety and Quality procedures and practices.