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Process Engineer, Upstream - Manufacturing Technical Operations

Company: Just - Evotec Biologics
Location: Redmond
Posted on: January 17, 2020

Job Description:

Just is seeking a highly motivated Process Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to provide project leadership for process transfer / tech transfer for clinical and commercial biologics manufacturing, including the development and maintenance of technical documentation within cGMP compliant systems. The selected candidate will also be responsible for troubleshooting and/or providing technical expertise to perform or lead investigations. In addition, this team member will also evaluate, develop, and implement new manufacturing technologies and equipment, including disposable-based systems and continuous processing technologies for a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility. The staff member may also provide person-in-plant support to partners, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections, and provide input to department capital and expense budgets. This position may work independently or supervise others. Position Requirements:

  • Bachelor's degree in engineering science or related program with 10+ years relevant experience
  • Extensive knowledge and hands on experience with biologics drug substance manufacturing processes
  • Considered a subject matter expert in the area of upstream processing, including single-use bioreactors and perfusion technology, but also knowledgeable in downstream process chromatography and filtration.
  • Experienced in leading technology and/or process transfer teams for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
  • Working knowledge of manufacturing process equipment and automation systems
  • Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
  • Ability to organize, analyze/interpret, and effectively communicate individual results
  • Good interpersonal, team, and collaborative skills are a must
  • Excellent oral and written communication skills Additional Preferred Qualifications:
    • Recognized technical mastery of disposable manufacturing technologies from bench-scale through commercial scale
    • 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
    • Ability to navigate global regulatory CMC documents
      About Just - Evotec BiologicsJust - 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

Keywords: Just - Evotec Biologics, Seattle , Process Engineer, Upstream - Manufacturing Technical Operations, IT / Software / Systems , Redmond, Washington

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