Validation Engineering Tech

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. The Role: We're looking for a passionate and curious Validation Engineer III to join our team. 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. 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

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

Experience with quality risk management

Knowledge of process equipment, utilities, operations, and engineering principles

Must possess a strong focus on quality and attention to detail

Motivated, self-starter with strong mechanical aptitude

Led a team or large validation projects

Working knowledge of shipping and cleaning

Working knowledge of utilities and facilities

Working knowledge of analytical equipment and systems

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.

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.

The base pay range for this position at commencement of employment is expected to be $115,000 to $126,500; 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. 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.