Process Engineering Specialist, Cell Culture

Just-Evotec Biologics is seeking a highly motivated Cell Culture Manufacturing Process Engineering Specialist 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 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 process transfer of cell culture operations from Process Development to Clinical Manufacturing. The staff member will also write and revise process documentation; participate in the evaluation of new manufacturing technologies; generate technical reports; assist in deviation investigation and CAPAs; and participate/provide key input to multidisciplinary project/technical teams. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures and manufacturing documentation.

Educational Requirements:

• Bachelor's degree in biological or engineering science with > 5 years relevant experience

Qualification Requirements:

• 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
• Proven knowledge of cGMP requirements to ensure compliance
• In-depth knowledge of equipment, operations, and engineering principles
• Applies knowledge and expertise to solve technical problems of moderate scope; may apply novel approach that provides significant technology advancement
• Can work independently and/or within groups and project teams

Additional Preferred Qualifications:

• Experienced with disposable manufacturing technologies from bench-scale through commercial scale
• Experienced in technology and/or process transfer for early stage clinical manufacturing
• Active participation in technical projects with collaborators and vendors
• Supervisory/leadership experience

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers