The Process Engineer will be heavily involved in managing the manufacturing and production systems for gene therapy operations. They are responsible for development and implementation of process platforms that are well characterized, efficient, scalable, cost-effective and that produce high-quality products in GMP and development environments. This entails requirements gathering, specifications development, validation support, troubleshooting, quality standards compliance and identification of continuous improvement projects on production products and processes. The successful candidate will be able to collaborate with Manufacturing, Process Development, Quality, Facilities, Automation, and external parties. They will provide technical and subject matter expertise in facilities readiness assessments, facilities design and renovation projects.
● Engage with internal and client process development organizations to prepare and maintain detailed layouts of simple to moderately complex viral vector, cell therapy, plasmids processes and related equipment, including block flow diagrams, process flow diagrams, piping & instrumentation diagrams, and equipment specifications
● Coordinate the process and technical input on facilities readiness design projects. This requires collaboration with architecture, engineering and construction providers.
● Identify needed process improvement, facilities reconfiguration and new capabilities projects. Engage and support project engineering staff for implementation.
● Lead manufacturing support activities for multiple advanced therapy bioprocess operations to ensure efficient production methods, continuous improvement and quality results.
● Confer with management, engineering, and other staff regarding manufacturing capabilities, production schedules, and other considerations to facilitate production processes.
● Design, develop, test, and/or source and cost-justify various tools, machinery, process equipment for recommended manufacturing methods and utility equipment for facilities infrastructure needs. Confer with vendors to determine product specifications and arrange for purchase of machinery and equipment according to specifications and quality standards.
● Ensures all project documentation is accurate and up-to-date (P&lDs, mechanical system drawings, automation documentation, etc.)
● Provide technical input to manufacturing on SOP changes, Deviations, GMP Investigations and CAPAs
● Represent manufacturing/engineering on cross-functional teams of scientists, automation engineers, facilities staff, and operations experts to develop, deploy, and rapidly improve process manufacturing solutions in a fast-paced startup environment.
● Apply statistical methods and perform product/process analysis for cost reduction, quality improvement, and improved efficiency.
● Author engineering specifications, internal standards and guidelines as part of the engineering team organization readiness efforts.
● Perform other related duties and special projects as assigned.
● 3-5+ years experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes
● Familiar with design specification and operation of bioprocess equipment, clean utilities, GMP facilities, and automation.
● Owner of smaller process or portion of larger process with guidance from senior staff.
● Willing and able to execute hands-on, clean room manufacturing support where necessary.
● Working knowledge of Unicorn Software, method writing and troubleshooting is a plus.
● Demonstrated skills:
o Comprehensive understanding of cGMPs
o Extensive biopharm process knowledge in at least one area: cell culture, fermentation & cell processing
o CAD/Bluebeam or other drawing editing capabilities
o EHS and Quality Minded
o Basic knowledge of Lean Principles Ability to Learn/Adapt
o Teamwork skills
o Independent problem solving skills
o Process flow/industrial flow
o Time management skills
o Effective communication skills
Education & Experience
B.S. or M.S. in Engineering or a Life / Physical Science with relevant work experience (Chemical Engineering preferred, others considered)