Principal Process Engineer - Downstream Manufacturing Technical Operations

Location
Redmond, WA, United States
Posted
Jun 20, 2021
Ref
1235061834
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Just is seeking a recognized leader 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 and organizational 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 support the implementation of 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.

Position Requirements:
  • B.S. or higher 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 downstream processing, including downstream process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration, but also knowledgeable in single-use bioreactors and perfusion technology.
  • Experience leading technology and/or process transfer teams for late stage clinical or commercial manufacturing
  • Demonstrated skills managing and mentoring direct reports
  • Familiar with process risk assessment tools (e.g. FMEA), developing process models, and process trending
  • Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
  • 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
  • Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems
  • Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Experience leading technical projects with external collaborators and vendors
  • Ability to navigate global regulatory CMC documents

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 200 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