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Process Engineer III/ Senior Process Engineer – Manufacturing Technical Operations

Employer
Just - Evotec Biologics
Location
Redmond, WA
Start date
Jul 29, 2022

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Job Details

Just is seeking a highly motivated Upstream 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 NPI late-stage molecule process transfer / tech transfer for clinical and commercial biologics manufacturing, including the support for development and maintenance of technical documentation for process control and validation strategies. The selected candidate will also be responsible for troubleshooting and/or providing technical expertise to perform or lead investigations. The staff member will also provide person-in-plant support to partners, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.

Position Requirements:

  • Bachelor’s degree in engineering science or related program with 7+ years relevant experience or 5+ years of relevant experience and a MS.
  • Practical expertise in cell culture biopharmaceutical manufacturing processes and applied technologies - including single-use bioreactors and perfusion technology.
  • Experienced in leading process transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/ commercial campaign support.
  • Ability to lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and routine manufacturing operations.
  • Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
  • Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle. Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
  • Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
  • Solid background in statistical analysis
  • Support creation, review and approval of technical documentation including protocols, batch records, and reports related to engineering, GMP and PPQ runs.
  • Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
  • Working knowledge of manufacturing process equipment and automation systems (DeltaV)
  • 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.
  • Project team leader for technology transfer of a Late-Stage molecule for a commercial plant and/or PPQ campaign support experience.
  • 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; provides technical advice to individuals within the team.
  • Active participation/lead technical projects with collaborators and vendors
  • High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.


Worker

Company

Just - Evotec Biologics, 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. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Find Us
Phone
206-651-5094
Location
401 Terry Avenue North
Seattle
98109
US
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