Validation Engineer II - Site based Redmond, WA
Validation Engineer II - Site based Redmond, WA
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Job Description
Job Title: Validation Engineer II
Location: Redmond WA
Department: MSAT team
Reports To: Director Validation
About Us: this is who we are
At Just Evotec Biologics 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 challenge in our journey
Were looking for a passionate and curious Validation Engineer II 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 a Validation Engineer II at Just Evotec Biologics 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.
One of the focuses of this job is to support manufacturing and laboratory equipment systems facilities and utilities commissioning qualification and validation activities required for clinical and commercial biologics manufacturing as part of a fast-paced and collaborative global validation team. These responsibilities span all phases of the lifecycle from system implementation and qualification to cleaning and shipping validation.
What Youll Do:
Support 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
Support development of robust collaboration for CSV and Process Validations
Support development and deployment of periodic review strategy for systems
Generate execute review and approval commissioning and qualification protocols for new manufacturing equipment systems facilities and utilities
Generate review and approval of requirements traceability matrices and qualification summary reports for new equipment and systems
Support validation deviation 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 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
Support CQV activities across global expansion sites
Who You Are:
Bachelors degree in engineering science or related program with the following years in relevant experience:
For Val Engineer II - 3 years
Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems equipment utilities and/or facilities
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 problem-solving and critical thinking skills
Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
High level oral and written communication skills are a must
Additional Qualifications:
Understanding of process automation (e.g. DeltaV)
Previous work experience with Complex Equipment Distributed Control System (DCS) Building Automation Systems (BAS) PLC SCADA PI and MES will be a plus
Applies knowledge and expertise to solve complex technical problems
Significant contributor to multi-disciplinary teams at the functional level
Working knowledge of the following: Utilities and facilities and computerized system analytical equipment and systemsand shipping and transport logistics cleaning validation methodologiesand process validation
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 Just Evotec Biologics
Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $79800 to $109250; 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 (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
