Validation Engineer III, Cleaning & Shipping

Evotec WD; Redmond (WA); On-site; USD 115,000 - 127,000; Full time

Benefits offered by this job

Discretionary annual bonus

Medical, Dental & Vision

Disability insurance

Life insurance

401k match

Flexible work

Paid time off

Wellness benefits

Transportation benefits

Job summary

Just - Evotec Biologics in Redmond, WA is seeking a Validation Engineer III to lead cleaning validation strategies for late-stage and commercial biologics manufacturing. You will develop and execute validation documents and work across CQV with Operations, Quality, Tech Transfer and external partners.

This role requires 7+ years in GMP pharmaceutical or biologics environments, strong problem-solving, and knowledge of FDA CFRs/ICH.

Qualifications

• Bachelor’s degree in engineering science or related field.
• 7+ years of relevant experience in validation within GMP pharma/biologics.
• Strong knowledge of cleaning validation and risk-based approaches.

Responsibilities

• Lead development and execution of phase-appropriate validation deliverables for cleaning and CQV.
• Develop Validation Master Plans and supporting documentation.
• Coordinate with cross-functional teams and external contractors to plan cycle development, qualification and validation activities.
• Author validation documentation including risk assessments, protocols, reports, and discrepancies.
• Lead validation discrepancy resolution and root cause analysis.

Skills

Cleaning validation

GMP experience

Problem-solving

Communication skills

Education

Bachelor's degree in engineering science or related program

Job description

Job Title

Validation Engineer III, Cleaning & Shipping

Location

Redmond, WA

Reports To

Director, Validation

About Us

At Just-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

We’re looking for a passionate and curious Validation Engineer III 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 Validation Engineer III, you’ll play a key role in developing and executing validation strategies supporting late-phase and commercial biologics manufacturing, with a primary focus on cleaning validation. As part of our collaborative global Validation team, you’ll partner across Operations, Logistics, Quality, Tech Transfer, Process Development, Engineering, and external vendors to develop and execute compliant, science- and risk-based validation programs. You’ll have the opportunity to take ownership of complex validation activities, lead investigations and problem-solving efforts, and contribute to validation strategies that support our growing biologics manufacturing network. The role may also support commissioning, qualification, and validation activities for manufacturing and laboratory equipment, facilities, utilities, and systems as business needs require.

What You’ll Do

• Lead the development and execution of phase-appropriate validation deliverables supporting global CQV strategies, with a focus on cleaning and shipping validation.
• Develop validation strategies and programs, including Validation Master Plans (VMPs) and supporting documentation.
• Liaise with the equipment, operations, logistics, qc, tech transfer, process development teams and third-party contractors, as applicable, to define and identify and perform cycle development, qualification and validation activities.
• Author validation documentation including, but not limited to, risk and gap assessments, cycle development protocols / reports / procedures, qualification/validation protocols and reports, and validation discrepancies.
• Lead validation discrepancy resolution, including troubleshooting, root cause analysis, and development of appropriate corrective actions.
• Support the development of the qualification and validation programs at Just including the transition from paper based to digital validation software to configure globally scalable end to end paperless solutions to manage the validation lifecycle.
• Develop and strategize compliant and novel ways to comply with regulatory requirements.
• Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings.
• Lead CQV activities across global expansion sites.

Who You Are

Bachelor’s degree in engineering science or related program with the following years in relevant experience: 7+ years

• Strong technical expertise in cleaning validation within a GMP pharmaceutical or biologics manufacturing environment.
• Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems and processes
• Working knowledge of US FDA CFRs and European EMA, including ICH regulations
• Experience with quality risk management
• Experience authoring, reviewing, and approving validation documentation
• Knowledge of process equipment, utilities, operations, and engineering principles
• Must possess a strong focus on quality and attention to detail
• Must possess problem-solving and critical thinking skills
• Motivated, self-starter with strong mechanical aptitude
• Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
• Excellent interpersonal, team, and communication skills are a must
• High level oral and written communication skills are a must
• Possess effective task/time management organizational skills

Additional Qualifications

Applies knowledge and expertise to solve complex technical problems Significant contributor to multi-disciplinary teams at the functional level Experience leading major validation projects or programs Working knowledge of process validation, utilities and facilities and analytical equipment/systems

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.
• 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.

Benefits

• 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

Compensation

The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500; Base salary offered may vary depending on individual’s skills, experience and competitive market value.

EEO

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.

About Evotec Biologics

Just - Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just - Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.