Senior Manager, Validation – Site MSAT

Job Title: Senior Manager of Validation

Location: Redmond, WA
Department: MSAT team
Reports To: Director, Manufacturing Tech Services

About Us: this is who we are

At Evotec, 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!

The Role: Your challenge…in our journey

We’re looking for a passionate and curious Senior Manager of Validation 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 Senior Manager of Validation at Evotec, 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.

What You’ll Do:

• Lead FUSE validation activities of early stage clinical manufacturing, late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
• Development, review and approval of technical documentation including validation lifecycle documents, validation protocols and associated reports related to the equipment validation lifecycle.
• In collaboration with cross functional teams, develop Validation Master Plans, provide process knowledge to support the validation execution and risk assessments.
• Support the development and implementation of templates and validation workflows.
• Support the generation of governance policies and related SOPs for commissioning of FUSE.
• Lead the periodic review of qualified/validated FUSE across JUST WA sites.

Who You Are:

• A curious problem-solver with a passion for learning and growing in a dynamic environment.
• Someone who is not satisfied with “just good enough” and is always looking to improve, adapt, and innovate.
• A natural collaborator who loves sharing ideas and learning from others.
• Comfortable with ambiguity and thrives in environments where curiosity and experimentation are encouraged.
• Excellent communicator, both verbally and in writing, able to share complex ideas in a simple, relatable way.
• A self-starter who takes initiative, owns your projects, and actively seeks out new challenges.

Education and Qualification Requirements

• Bachelor’s degree in engineering science or related program with 8+ years relevant experience or 6+ years of relevant experience with an MS.
• Proven experience in leading commissioning and validation activities of FUSE.
• Understanding of GMP concepts and Quality systems necessary to execute validation activities.
• Experience developing and providing oversight to validation strategies throughout the FUSE validation life cycle.
• Understand computer system validation requirements.
• Understanding of FDA CFR 21 Part 11 compliance
• Strategic mindset, ability to organize, analyze/interpret, and effectively translate validation expertise into 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
• Working knowledge of biologics manufacturing process equipment, engineering and utility systems, DeltaV automation systems, and Manufacturing Execution Systems
• Have experience leading validation projects from early stage to late stage manufacturing.
• Experience with single-use technologies and systems
• Authority inspection or audit support involvement.

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, whether that means working remotely or choosing a hybrid model.
• 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.

Are You Still Curious?

If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of Evotec.

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

The base pay range for this position at commencement of employment is expected to be $112,560 to $154,100; 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, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec 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.

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.