Process Engineer II/III, Cell Culture

Just Biotherapeutics - Seattle, WA (26 days ago)


Just is seeking a highly motivated cell culture manufacturing Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for the manufacture of mammalian cell-based biotherapeutics for clinical and commercial use under cGMP conditions. Under limited/minimal supervision, the primary job responsibilities include setup, operation and troubleshooting of disposable-based manufacturing equipment; execution of manufacturing process operations; and execution of commissioning and validation activities. The staff member may also assist supervisor with day-to-day activities; train new and existing Process Engineers; write and revise process documentation; participate or lead the evaluation of new manufacturing technologies; generate technical reports or process documentation; and participate/provide key input to multidisciplinary project/technical teams. The staff member is expected to comply and following written procedures for safety requirements, cGMP Practices, Standard Operating Procedures and manufacturing documentation.

Educational Requirements:
Bachelors degree in biological or engineering science with 4-8+ years relevant experience

Minimum Qualifications

Candidate must possess strong focus on quality and attention to detail
Possess effective task/time management organizational skills
Capacity to develop solutions to technical issues of moderate scope
Ability to organize, analyze/interpret, and effectively communicate individual results
Motivated, self-starter with strong mechanical aptitude
Good interpersonal, team, and communication skills are a must
Excellent oral and written communication skills

Preferred Qualifications:
In-depth knowledge of equipment, operations, and engineering principles
Recognized technical mastery of disposable manufacturing technologies from bench-scale through commercial scale
Proven knowledge of cGMP requirements to ensure compliance
Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
Can work independently and/or manage the activities of individuals, work group, or project teams; significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
Active participation/lead technical projects with collaborators and vendors

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. Just is developing a portfolio of molecules that best leverages our technological strengths. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.