Validation Engineer III

Cyprotex Limited; Redmond (WA); Sur place; USD 115 000 - 127 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

401k with company match

Paid time off & holidays

Wellness benefits

Résumé du poste

Evotec (US) Inc. in Redmond, WA is seeking a Validation Engineer III who will drive validation activities for late-phase and commercial biologics manufacturing.

You will lead cross-functional teams across CQV, equipment, and QC/Analytical domains to develop strategies and validate processes and systems. The role emphasizes adherence to regulatory requirements, capability in risk-based qualification, and collaboration with global teams to enable scalable, digital validation solutions.

Qualifications

• Bachelor’s degree in engineering with 7+ years in Validation Engineering.
• Experience with US FDA CFRs and European EMA, including ICH regulations.
• Experience authoring, reviewing, and approving validation documentation.
• Knowledge of process equipment, utilities, operations, and engineering principles.
• Strong focus on quality and attention to detail.

Responsabilités

• Lead deliverables as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping.
• Document strategy for validation programs including master plans.
• Coordinate with cross-functional teams to define and perform cycle development, qualification and validation activities.
• Author validation documents including risk assessments, protocols, reports, and validation discrepancies.
• Lead validation discrepancy resolution including root cause analysis.
• Support transition from paper-based to digital validation software for end-to-end lifecycle management.

Connaissances

FDA CFRs knowledge

Quality risk mgmt

Validation docs authoring

Process equipment knowledge

Independent & team work

Communication skills

Time management

Mechanical aptitude

Problem solving

Attention to detail

GMP mindset

Formation

Bachelor's in Engineering

Outils

Computerized systems

Analytical equipment

Description du poste

Job Title

Validation Engineer III

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? #BeCurious 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:Validation Engineer III - 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
• 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 shipping and cleaning
• Working knowledge of process validation
• Working knowledge of utilities and facilities
• Working knowledge of computerized system
• Working knowledge of analytical equipment and 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.

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.