Validation Engineer III

Evotec

Validation Engineer III at Just-Evotec improving worldwide access to biotherapeutics. Lead validation activities for biologics manufacturing with a focus on compliance and quality.

Posted 6/3/2026full-timeRedmond • Washington • 🇺🇸 United StatesSeniorLead💰 $115,000 - $126,500 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Bachelor's degree in engineering science or related program
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

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

validation master plansrisk assessmentsgap assessmentscycle development protocolsqualification protocolsvalidation discrepanciesquality risk managementengineering principlesdigital validation softwarecompliance strategies

Soft Skills

problem-solvingcritical thinkingattention to detailself-starterinterpersonal skillsteam collaborationcommunication skillstask managementorganizational skillsindependence

Certifications

Bachelor's degree in engineering science