Process Engineer III - Site Based, Redmond, WA
Evotec
Summary
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.
Job description
What You'll Do
- 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.
Who You Are
- 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
Additional Preferred Qualifications
- 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
Requirements
- Bachelor's degree in engineering, sciences, or related program with 5+ years of relevant experience, or MS degree with 2 years of experience
- Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry
- Familiar with process risk assessment tools (e.g., FMEA), developing process models, and process trending
- Solid understanding of downstream processing including process chromatography, continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration
- Solid understanding of GMP concepts and quality systems
- Hands on experience of downstream disposable-based manufacturing technologies from bench-scale through commercial scale
- Working knowledge of manufacturing process equipment and automation systems
- Strong focus on quality and attention to detail
- Effective task/time management and organizational skills
- Ability to organize, analyze/interpret, and effectively communicate process data
- Good interpersonal, team, and collaborative skills
- Excellent oral and written communication skills
Benefits
- Medical, Dental & Vision
- Short-term disability
- Long-term disability
- Company paid basic life insurance
- 401(k) Matching
- Paid Time Off
- Paid Holidays
- Wellness Benefits
- Transportation Benefits
- Discretionary Annual Bonus
Company overview
Evotec SE is a leading German drug discovery and development partnership company headquartered in Hamburg, Germany. Founded in 1993 by Nobel Laureate Manfred Eigen and other scientists, Evotec operates as a contract research organization (CRO) that collaborates with pharmaceutical companies, biotechs, academic institutions, and government agencies to advance therapeutic innovations. The company employs approximately 4,788 professionals worldwide and specializes in small molecule drug discovery across multiple therapeutic areas including oncology, neurological disorders, metabolic diseases, cardiovascular conditions, inflammation, pain, and respiratory diseases. Evotec's comprehensive service portfolio encompasses target identification and validation, hit identification, in vitro pharmacology, integrated CMC services, and proteomics. With facilities across Europe and the United States, the company has established long-term strategic alliances with major pharmaceutical partners including Bristol Myers Squibb, Bayer, Sanofi, Boehringer Ingelheim, and Eli Lilly. Evotec's innovative Pipeline Co-Creation model represents a flexible, multi-modality approach to drug development, leveraging data-driven disease understanding and AI technologies to accelerate the delivery of quality drug candidates.