Process Engineer II/III Manufacturing Technical Operations, Upstream
Company: Just - Evotec Biologics
Location: Redmond
Posted on: May 7, 2022
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 lead process transfer for clinical
and commercial biologics into a first-of-its-kind flexible and
reconfigurable cGMP manufacturing facilityThe selected candidate
will be responsible for working with process development to develop
process transfer documents and support the development of
manufacturing batch records and operating procedures for the
process. In addition, the candidate will be responsible for
supporting the commissioning and validation of new process
equipment in the facility, supporting process engineering
activities, including 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 5+ years relevant experience.
- Significant experience leading process transfer / technology
transfer projects and teams in the biopharmaceutical industry;
commercial manufacturing campaign support is a plus
- Familiar with process risk assessment tools (e.g., FMEA)
developing process models, and process trending.
- Solid understanding of upstream processing including single-use
bioreactor operations and perfusion technology.
- Hands on experience of 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 as well as effective task/ time management organizational
skills
- Ability to organize, analyze/interpret, and effectively
communicate process data
- Good interpersonal, team, and collaborative skills are a
must
- Excellent oral and written communication skillsAdditional
Preferred Qualifications:
- Recognized technical mastery of upstream disposable
manufacturing technologies from bench-scale through commercial
scale.
- 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
- Experience with DeltaV for process controlAbout Just Evotec
BiologicsEstablished in 2014, Just Biotherapeutics, Inc. was
acquired by Evotec SE in 2019. 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. Worker
Keywords: Just - Evotec Biologics, Redmond , Process Engineer II/III Manufacturing Technical Operations, Upstream, IT / Software / Systems , Redmond, Washington
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