Automation Engineer Details

Automation Engineer

MaxCyte - Gaithersburg, MD

Employment Type : Full-Time

Automation Engineer

About MaxCyte:

MaxCyte is a leading provider of cell-engineering platform technologies to advance
innovative cell-based research, development, and commercialization of next-generation cell
therapies. The company's existing customer base ranges from large biopharmaceutical
companies — including 20 of the top 25 pharmaceutical companies based on 2020 global
revenue — to hundreds of biotechnology companies and academic translational research
centers. MaxCyte has granted 16 strategic platform licenses to commercial cell therapy
developers that allow for more than 75 clinical programs. Founded in 1998, MaxCyte is
headquartered in Gaithersburg, Maryland, US.

Job Summary:

The Automation Engineer will support manufacturing operations with a focus on small and
large-scale development, implementation, and maintenance of automation systems for
MaxCyte’s Process Assemblies (PA) ensuring efficiency and product quality.

Job Duties:

• Conceptualize fully automated and semi-automated assembly systems and mechanisms

to support high volume continuous flow production lines.

• Participate in the design for manufacturing process for MaxCyte’s Process Assemblies

(PA)

• Project manage the construction, implementation and validation of automation

equipment, systems, and processes. Ensuring project delivery, meeting deadlines,
budget, and quality goals.

• Write IQ/OQ/PQ protocols and reports and execute the qualification process.

• Develop automation specifications and standards.

• Maintain automation equipment including setup, repair, and preventative maintenance.

• Evaluates and recommends process improvements utilizing LEAN principles. Optimize

manufacturing automation systems.

• Conducts all activities in compliance with Standard Operating Procedures and

Manufacturing Batch Records outlined in MaxCyte’s Quality Management System.

• Drafts and reviews procedures and work instructions for manufacturing and operations

processes. Maintain technical documentation (manuals, drawings, software, etc.).

• Provides technical support to facilitate quality investigations, root cause analysis and

corrective action/preventive action (CAPA) implementation.

• Initiates engineering change requests as functional change owner and oversees the

execution and implementation of proposed changes.

• Supports internal and external audits and quality system certification.

• Assisting with other design and/or development activities.

• Complies with all applicable policies regarding health, safety, and environmental

policies.

• Other responsibilities as assigned.

Job Requirements:

• Bachelor’s degree in Mechanical, electrical, Instrumentation or Biomedical Engineering

or other related discipline with at least 3-5 years of hands-on manufacturing automation
specific to medical devices and/or laboratory equipment is required; or 10+ years of
relevant work experience.

• Mechanical design, SolidWorks

• Programmable Logic Controller (PLC)

• Prior experience with software development / programming for customization of user

interface is desirable.

• Machine Shop experience

• Familiarity with manufacturing processes and design control

• Demonstrated computer skills; experience using MS Office [Word, Excel, PowerPoint]

• Able to troubleshoot mechanical and electrical components

• Customer oriented. Resolves customer problems and issues through technical

expertise and troubleshooting

• Prior experience with LEAN manufacturing principles and is highly desirable

• Working knowledge of QSR, GMP, and ISO requirements preferred

• Team-oriented individual with strong verbal, written and interpersonal skills

• Has a “do what it takes” attitude to meet customer deadlines

• Minimum travel – less than 10%

• Work in cleanrooms that requires full gowning

• Work extended periods on feet in a cleanroom manufacturing environment

• Lift/carry 40 lbs.

• Work from ladders/step stools

MaxCyte, Inc. is an equal opportunity employer. To apply, please send your resume and/or
cover letter to careers@maxcyte.com. Please reference Automation Engineer in the subject
line.