Process Engineer III - Site Based, Redmond, WA

Evotec•Redmond, WA

17h•$92,400 - $126,500•Onsite

About The Position

Just Evotec Biologics is seeking a highly motivated Process Engineer specializing in downstream processing to join their Global MSAT team. This role is a significant opportunity to improve worldwide access to biotherapeutics. The selected candidate will support the Tech Transfer Leads with the implementation of network alignment strategy and the creation of global templates and documentation for Tech Transfer/New Product Introduction across Just Evotec. The primary focus is to support site-to-site downstream tech transfer for late-stage clinical and commercial biologics across the Manufacturing network. The role may also involve person-in-plant support, assisting in the generation of relevant regulatory submissions, and providing 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.
Ensure 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.