Validation Engineer III

Evotec•Redmond, WA

1d•$115,000 - $126,500•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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