Process Engineer I/II, Upstream - Manufacturing Technical Operations

Location
Redmond, WA, United States
Posted
Oct 22, 2020
Ref
1876752072
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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 support the startup of a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility. The selected candidate will be responsible for supporting the procurement, commissioning, and testing of the process equipment for the new facility, including developing commissioning documentation and standard operating procedures. In addition, the candidate will be responsible for supporting process engineering activities for the new manufacturing plant, including process transfer / tech transfer for clinical and commercial biologics manufacturing, writing technical documentation within cGMP compliant systems, troubleshooting equipment, and introducing new manufacturing technologies such as continuous processing. 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:
  • Bachelor's degree in engineering science or related program with 1-3 years relevant experience
  • Understanding of upstream equipment and operations used to manufacture biotherapeutics
  • Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
  • Hands on experience with single use bioreactor operations and 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 as well as effective task/ time management organizational skills
  • Experience /proficient in technical writing and authoring SOPs
  • 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:
  • Experience with Delta V controls and data collection
  • Applies knowledge to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Can work independently and in project teams; significant contributor to multi-disciplinary teams at the functional level
  • Ability to navigate global regulatory CMC documents
  • Experience with equipment commissioning/validation activities

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