Process Engineer III - Site Based, Redmond, WA

Evotec WD; Redmond (WA); On-site; USD 92,000 - 127,000; Full time

Job summary

Just Evotec Biologics is seeking a passionate Process Engineer III to join the Global MSAT Tech Transfer team. This role focuses on downstream tech transfer for late-stage biologics across the manufacturing network and requires expertise in continuous chromatography, large-scale column packing, viral filtration, and tangential flow filtration.

Strong collaboration and regulatory documentation experience are essential.

Qualifications

• Bachelor's degree in engineering, sciences, or related program with 5+ years of relevant experience, 2 years with an MS degree.
• Experience supporting process transfer/technology transfer projects in biopharmaceuticals; commercial manufacturing campaign support is a plus.
• Familiar with process risk assessment tools (FMEA), developing process models, and process trending.

Responsibilities

• Support downstream technology transfer of late-stage molecule/PPQ campaigns.
• Support site-to-site Tech Transfer activities and regulatory document generation.
• Develop/approve technical documentation including global protocols for PPQ and CPQ runs.
• Author Process Validation and Continued Process Verification strategies.
• Conduct process data analysis, including annual reviews across network sites.

Skills

Process transfer

FMEA

GMP knowledge

Data analysis

Downstream chromatography

Process modeling

Disposables manufacturing

Communication

Team collaboration

Education

Bachelor's degree in engineering or sciences

MS degree (preferred)

Tools

DeltaV

Job description

**Job Title:** Process Engineer III**Shifts:** Monday to Friday, DaysAt **Just** **Evotec Biologics**, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged - it's celebrated.**#BeCureious** with us and see where your curiosity can take you!**The Role: / your challenge, ...in our journey**We're looking for a passionate and curious [Job Title] to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.As a **Process Engineer III** at **Just** **Evotec Biologics**, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team. 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.**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 skillsAdditional 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**Why Join Us:*** **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. Site based role.* **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.##**Just** **Evotec Biologics**.Let your curiosity guide your career - **#BeCurious** and explore the endless possibilities at **Just** **Evotec Biologics**!The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; this is a salary exempt role. Base salary offered may vary depending on the individual's skills, experience and competitive market value. Additional total rewards include 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.Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.