Process Engineer III - Site Based, Redmond, WA

Cyprotex•Redmond, WA

4d•$92,400 - $126,500•Onsite

About The Position

Just is seeking a highly motivated Process Engineer downstream in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics. The selected candidate as part of the Global MSAT Tech Transfer team supports Tech transfer leads with the implementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across JUST Evotec. The primary focus of this job is to support site to site downstream tech transfer for late stage clinical and commercial biologics across the Manufacturing network. The staff member may also provide person-in-plant support, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections.

Requirements

Bachelor’s degree in engineering, sciences, or related program with 5 + years of relevant experience, 2 years of experience with an MS degree
Experience supporting 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 downstream processing including process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration either at Manufacturing scale or in process development of biologics.
Solid understanding of GMP concepts and quality systems necessary to support Tech Transfer and process validation activities.
Hands on experience of downstream 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 skills

Nice To Haves

Practical experience or knowledge downstream and disposable manufacturing technologies either at Manufacturing scale or at bench-scale.
Applies knowledge to solve complex technical problems.
Technical resource for Downstream Manufacturing process and platform.
Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec.
Ability to navigate global regulatory CMC documents.
Experience with supporting late-stage manufacturing, Tech transfer and or Process Validation studies
Experience with DeltaV for process control

Responsibilities

Support downstream technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
Support site to site Tech Transfer activities
Support 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 support of late stage/commercial manufacturing operations.
Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs.
Author templates for Process Validations and Continued Process Verification strategies.
Conduct the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
Author Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the Just MFG network.

Benefits

Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
short-term and long-term disability
company paid basic life insurance
401k company match
generous paid time off and paid holiday
wellness and transportation benefits