Validation Engineer III

Just-Evotec Biologics • Redmond, WA

17h • Onsite

About The Position

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 7+ years in relevant experience
• 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

Benefits

• Medical
• Dental
• Vision
• short-term and long-term disability
• company paid basic life insurance
• 401k company match
• flexible work
• generous paid time off
• paid holiday
• wellness and transportation benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior