Validation Engineer III
Validation Engineer III
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Job Description
Job Title: Validation Engineer III
Location: Redmond
Department: Manufacturing
Reports To: Dir Validation
About Us: this is who we are
At 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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.
Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCUREious with us and see where your curiosity can take you!
The Role: Your challengein our journey
Were looking for a passionate and curious Validation Engineer III to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect fit. In this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As Validation Engineer III at Evotec youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
What Youll 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 / proceduresqualification/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:
A curious problem-solver with a passion for learning and growing in a dynamic environment.
Someone who is not satisfied with just good enough and is always looking to improve adapt and innovate.
A natural collaborator who loves sharing ideas and learning from others.
Comfortable with ambiguity and thrives in environments where curiosity and experimentation are encouraged.
Excellent communicator both verbally and in writing able to share complex ideas in a simple relatable way.
A self-starter who takes initiative owns your projects and actively seeks out new challenges.
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 process validation utilities and facilitiesand analytical equipment and systems
Education and Qualification Requirements
Bachelors 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
Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
Why Join Us:
Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life whether that means working remotely or choosing a hybrid model.
Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.
Are You Still Curious
If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Evotec.
Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Evotec!
The base pay range for this position at commencement of employment is expected to be $92400 to $126500;Base salary offered may vary depending on the individuals 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 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.
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.
Employment Type
Full-Time
