Process Engineer II/Specialist – Cell Culture

Location
Seattle, WA
Posted
Oct 04, 2021
Ref
REQ-03898
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Just is seeking a highly motivated and creative purification Process Engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. The new Engineer will join a fast-paced, collaborative, and multidisciplinary team responsible for the manufacture of mammalian cell-based biotherapeutics for clinical use. The focus of this job is to guide the execution of manufacturing operations while ensuring cGMP compliance, provide project leadership as a lead or technical resource, and to develop, assess and implement disposable-based manufacturing technologies. This position may supervise others and requires a significant on the floor presence. Additional job responsibilities may include troubleshooting and/or providing technical expertise to perform or lead investigations, ensuring staff training compliance, developing and maintaining manufacturing and technical documentation. The staff member may also lead aspects of technical operations and technology transfer; act as a functional lead for new product introduction; participate or lead the evaluation of new manufacturing technologies; and participate/provide key input to multidisciplinary project/technical teams. As a key member of the upstream group, the successful candidate will be highly knowledgeable regarding upstream processing including single-use bioreactor operations and perfusion technology and have significant experience executing these techniques at scale.

Qualifications and Education Requirements:

  • Bachelor’s degree in biological or engineering science with 5+ years relevant experience
  • Solid understanding of upstream processing including single-use bioreactor operations and perfusion technology
  • Hands on experience with upstream disposable-based manufacturing technologies from bench-scale through commercial scale
  • Working knowledge of manufacturing process equipment and automation systems
  • 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 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:

  • Recognized technical mastery of upstream disposable manufacturing technologies from bench-scale through commercial scale
  • Proven knowledge of cGMP requirements to ensure compliance
  • Change control, NC/CAPA, and deviations
  • Fundamental understanding and basic operation of process automation (DeltaV)
  • Experienced in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Experience applying knowledge and expertise to solve complex technical problems; may apply novel approaches that provides significant technology advancement
  • Ability to work independently and in project teams; significant contributor to multi-disciplinary teams at the functional level
  • Experience as an active participant/lead in technical projects with collaborators and vendors

About Just

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 200 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. 

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