Validation Engineer III

Life Science Washington; Redmond (WA); On-site; USD 115,000 - 127,000; Full time

Benefits offered by this job

Medical and dental benefits

401k with company match

Paid time off

Job summary

Just-Evotec is seeking a Validation Engineer III to lead cleaning, shipping and process validation activities for late phase and commercial biologics manufacturing. You will design validation programs, generate master plans, and coordinate with equipment, operations, QC/Analytical, tech transfer and third parties.

The role emphasizes global CQV strategy, risk-based approaches, and progressing digital validation tools while supporting audits and inspections in a fast-paced environment.

Qualifications

• Bachelor's degree in engineering with 7+ years in validation.
• Experience with US FDA CFRs and European EMA including ICH regulations.
• Expert knowledge of cleaning and shipping.
• Experience with quality risk management.
• Experience authoring, reviewing, and approving validation documentation.
• Knowledge of process equipment, utilities, operations, and engineering principles.

Responsibilities

• Lead generation of key deliverables in a phase-appropriate compliance manner as part of global CQV strategy for F/U, Equipment, QC/Analytical, Cleaning and Shipping.
• Document a strategy for validations programs including the generation of validation master plans.
• Liaise with cross-functional teams to define and perform cycle development, qualification and validation activities.
• Author validation documentation including risk assessments, cycle development protocols/reports, validation protocols and reports.
• Lead validation discrepancy resolution including troubleshooting and root cause analysis.
• Support digital validation software transition to globally scalable end-to-end paperless solutions.
• Develop compliant and novel ways to satisfy regulatory requirements.
• Support inspection readiness activities and audits; assist with corrective actions.
• Lead CQV activities across global expansion sites.

Skills

CQV strategy

Validation master plans

Regulatory alignment

Root cause analysis

Documentation writing

Team collaboration

Troubleshooting

Education

Bachelor's degree in engineering

Tools

Digital validation software

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.

Just-Evotec is seeking a highly motivated Validation Engineer III that desires a significant opportunity to improve worldwide access to biotherapeutics. A few focus areas of this job include to strategize, implement and support cleaning, shipping and process validation activities required for late phase and commercial biologics manufacturing as part of a fast-paced and collaborative global validation team. Manufacturing and laboratory equipment, systems, facilities, and utilities commissioning, qualification and validation activities maybe supported as part of this role as required.

What You’ll Do:

• Lead the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping
• Document a strategy for validations programs including the generation of validation master plans
• 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 and root cause analysis
• 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
• 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
• Expert knowledge of shipping and cleaning
• 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
• Led a team or large validation projects
• Working knowledge of process validation,utilities and facilities andanalytical 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.

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

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. 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.