Senior Process Validation Engineer - Site based, Redmond, WA

Job Title: Senior Process Validation Engineer Global MSAT

About Us: this is who we are

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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper

#BeCUREious with us and see where your curiosity can take you!

The Role: / your challenge in our journey

Were looking for a passionate and curious Senior Process Validation Engineer to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a Senior Process Validation Engineer at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

Just is seeking a highly motivated Senior Process Validation 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 of process validation and tech transfer activities for late-stage programs into PPQ/ commercial biologics manufacturing. The selected candidate as part of the Global MSAT Tech Transfer and Process Validation team is responsible for supporting the implementation of network alignment strategy and creation of global templates/documentation for Process Validation across JUST Evotec Manufacturing network. The team member will also provide support for new facility startup engineering runs execution of performance qualification runs assist in generation of relevant regulatory submissions and provide support for regulatory and site inspections.

What Youll Do:

• Project Lead for Process Validation and/or Tech Transfer activities of late-stage molecule/ commercial manufacturing and/or PPQ campaign support.

• Support technology transfer activities ensuring process 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.

• In collaboration with cross functional teams develop Process Validation Master Plans provide process knowledge to support Process Characterization and perform Process Validation risk assessments.

• Support development review and approval of technical documentation including global protocols for Process Performance Qualification runs Process Validation studies and associated reports related to engineering GMP and PPQ runs.

• Support the development and implementation of templates for Process Validation and Continued Process Verification strategies.

• Support the generation of governance policies and related SOPs for Process Validation

• Manage project-specific deliverables including but not limited to PVMP PPQ protocols and supporting validation such as mixing hold time studies impurity clearance extractables & leachables filter validation etc.

• Support technology transfer activities ensuring process 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 the analysis of process data including annual periodic reviews across the network of Manufacturing sites.

Who You Are:

• Bachelors degree in engineering science or related program with 10 years relevant experience or 8 years of relevant experience with an MS.

• Proven experience in leading Process Validation activities for late-stage clinical manufacturing PPQ campaigns/ commercial campaign support.

• Understanding of GMP concepts and Quality systems necessary to execute 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

• Strategic mindset ability to organize analyze/interpret and effectively translate process validation expertise into global procedures/templates

• Demonstrated skills managing or mentoring junior engineers or direct reports.

• Proven knowledge of cGMP requirements and experience writing manufacturing technical documents

• Experience leading technical projects and managing timelines with external collaborators and vendors

Additional Preferred Qualifications:

• Expertise in the area of either upstream or downstream processing including downstream process chromatography and specifically continuous chromatography large scale column packing viral filtration and tangential flow filtration single-use bioreactors and perfusion technology.

• Working knowledge of manufacturing process equipment DeltaV automation systems and Manufacturing Execution Systems

• Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement

• High level of demonstrated initiative exhibit flexibility in work approach and demonstrate strong follow through and accountability.

• Ability to navigate global regulatory CMC documents

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. Site based.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.

Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $112560 to $154100; Base salary offered may vary depending on the individuals 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 flexible work 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.