Validation Engineer II RedmondSeattle, WA, Site Based

Job Title: Validation Engineer II

Location: Redmond Seattle WA

Shifts: Monday to Friday 8:00am till 5:00pm

Some flexibility as may be required as business needs to come in over the weekend.

About Us: this is who we are

At Just Evotec Biologic 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 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 Biologic 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.

The primary focus of this job is to support manufacturing and laboratory equipment systems facilities and utilities commissioning qualification and validation activities required in early phase manufacturing to late-stage programs into PPQ/ commercial biologics manufacturing. These responsibilities span all phases of the lifecycle from system implementation and qualification to cleaning and shipping validation. This role will also work cross functionally and collaborate with other teams on validation projects.

What Youll Do:

Execute FUSE commissioning and validation activities for early stage clinical manufacturing late-stage molecule/ commercial manufacturing and/or PPQ campaign support.

Generate and review technical documentation including validation lifecycle documents validation protocols and associated reports related to the equipment validation lifecycle.

In collaboration with cross functional teams develop Validation Master Plans provide process knowledge to support the validation execution and risk assessments.

Lead the development and implementation of templates and validation workflows.

Support the generation of governance policies and related SOPs for commissioning of FUSE.

Support validation deviation resolution including troubleshooting and root cause analysis

Support the periodic review of qualified/validated FUSE across JUST WA sites.

Support inspection readiness activities Health Authority and Client audits and support corrective actions based on audit findings

Who You Are:

Bachelors degree in engineering science or related program with minimum 2 years relevant experience.

Proven experience in executing commissioning and validation activities of FUSE.

Understanding of GMP concepts and Quality systems necessary to execute validation activities.

Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems equipment utilities and/or facilities

Knowledge of process equipment utilities operations and engineering principles

Experience in quality risk management

Must possess problem-solving and critical thinking skills

Good interpersonal team and collaborative 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

Proven knowledge of cGMP requirements and experience writing manufacturing technical documents

Experience leading technical projects and managing timelines with external collaborators and vendors

Candidate must possess a strong focus on quality and attention to detail as well as effective task/ time management organizational skills

Additional Preferred Qualifications:

Understanding of biologics manufacturing process and process automation (e.g. DeltaV)

Experience with single-use technologies and systems

Previous work experience with Complex Equipment Distributed Control System (DCS) Building Automation Systems (BAS) PLC SCADA PI and MES will be a plus

Working knowledge of utilities and facilities computerized systems analytical equipment process validation and clean validation methodologies.

Significant contributor to multi-disciplinary teams at the functional level

Authority inspection or audit support involvement.

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. Site based role.

• 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 Biologic.

Let your curiosity guide your career#BeCurious and explore the endless possibilities at Just Evotec Biologic!

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.