Senior Process Engineer - Site Based, Redmond, WA

Evotec • Redmond, WA

4d • $112,560 - $154,100 • Onsite

About The Position

At 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. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

We’re looking for a passionate and curious Senior Process Engineer 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 Senior Process Engineer, 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 Senior Upstream Process Engineer in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to provide project leadership for late-stage molecule process transfer / tech transfer for clinical and commercial biologics manufacturing, including the support for development and maintenance of technical documentation for process control and validation strategies. The selected candidate as part of the Global MSAT Tech Transfer team is responsible for supporting the implementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across Just Evotec Biologics Manufacturing network. The team member will also provide onsite support for new facility startup engineering runs and performance qualification runs, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.

Requirements

• Bachelor’s degree in engineering, science or related program with 10+ years relevant experience or 8+ years of relevant experience with an MS.
• Considered a subject matter expert in cell culture biopharmaceutical manufacturing and or development of cell culture processes including perfusion technologies, single use bioreactor operations, and scale-up strategies.
• Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/ commercial campaign support.
• Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
• Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
• Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
• Solid background in statistical analysis
• Significant experience with process risk assessment tools (e.g. FMEA) and facilitating risk assessments.
• Working knowledge of manufacturing process equipment and automation systems (DeltaV)
• Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
• Strategic mindset, ability to organize, analyze/interpret, and effectively translate upstream expertise into global procedures/templates.

Nice To Haves

• Recognized technical mastery of cell culture unit operations including perfusion technologies, continuous processing disposable manufacturing technologies from bench-scale through commercial scale.
• Knowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technology advancement.
• Experience leading technical projects with external collaborators and vendors
• Ability to navigate global regulatory CMC documents.
• High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.

Responsibilities

• Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
• Lead site to site Tech Transfer activities
• Lead 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.
• Support the development and implementation templates for Process Validations and Continued Process Verification strategies.
• Support the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
• Develop 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
• Flexible Work Environment
• Inclusive Culture
• Innovative Projects
• A Place for Big Ideas
• 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, flexible work, generous paid time off and paid holiday, wellness and transportation benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees