Technical Support Engineer

Location
Gaithersburg, MD, United States
Posted
Dec 24, 2020
Ref
381706739
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
About MaxCyte:

Job Summary:

The Technical Support Engineer provides operational support related to field/customer issues, instrument verification, manufacturing , troubleshooting, manufacturing test design , and technical maintenance of instrumentation and software. Works independently. This individual reports to the Director of Engineering and Manufacturing.

Job Responsibilities:

• Participates in the installation, calibration, operational and performance qualification of the instrumentation systems
• Provides training, technical support, and application customization at customer and/or partner sites or virtually .
• Conducts all activities in compliance with Standard Operating Proce dures and Manufacturing Batch Records outlined in MaxCyte's Quality Management System.
• Interacts with external collaborators and/or customers from time - to - time and may need to travel.
• Drafts and reviews procedures and work instructions for manufacturin g and operations processes .
• Provides operational support and monitors assembly process control . Evaluates and recommends process improvements utilizing LEAN principles. MaxCyte, the clinical- stage global cell-based therapies and life sciences company, uses its proprietary next- generation cell and gene therapies to revolutionize medical treatments and ultimately save lives. The Company's premier cell engineering enabling technology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licenses have been granted to more than 120 cell therapy programs, with more than 90 licensed for clinical use, and the Company has now entered into ten clinical/commercial license partnerships with leading cell therapy and gene editing developers. MaxCyte was founded in 1998, is listed on the London Stock Exchange (AIM:MXCT, MXCL) and is headquartered in Gaithersburg, Maryland, US. For more information, visit www.maxcyte.com.
• Provides technical support to facilitate quality investigations, root cause analysis and corrective action/preventive action (CAPA) implementation
• Initiates engineering change request s as functional change owner and oversees the execution and implementation of proposed change s.
• Supports internal and external audits and quality system certification
• Supports ongoing product enhancement activities
• A ssists with other design and/or development activities.
• Complies with all applicable policies regarding health, safety, and environmental policies.
• Other responsibilities as assigned

Job Qualifications:

• B.S. / M.S. in Mechanical, Instrumentation , Biomedical or Electrical Engineering or other related discipline with at least 2 - 5 years of hands - on assembly and testing of instrumentation systems specific to medical devices and/or laboratory equipment; or 10+ years of relevant work experience.
• Prior experience with software development / programming for customization of user interface is desirable.
• Demonstrated computer skills; experience using MS Office [Word, Excel, PowerP oint]
• Able to troubleshoot mechanical and electrical components
• Customer oriented. Resolves customer problems and issues through technical expertise and troubleshooting
• Familiarity with manufacturing processes and design control
• Prior experience with L EAN manufacturing principles and is highly desirable
• Working knowledge of QSR, GMP, and ISO requirements
• Team - oriented individual with strong verbal, written and interpersonal skills
• Has a "do what it takes" attitude to meet customer deadlines
• Approximately 10% travel MaxCyte, Inc. is an equal opportunity employer.