Validation Engineer II - Site , Redmond, WA

Position: Validation Engineer II - Site Based, Redmond, WA
*
* Location:

** Redmond/Seattle, WA
*
* Shifts:

** Monday to Friday, 8:00am - 5:00pmMay be required for weekend work due to business needs.

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 what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated.**#Be Cureious
** with us and see where your curiosity can take you!
*
* The Role:

/ your challenge, …in our journey
** We’re looking for a passionate and curious
** Senior Process Validation Engineer
** 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.

As a
** Senior Process Validation Engineer
** at
** Just*
* ** Evotec Biologic**, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s 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 provide project leadership of process validation and tech transfer activities for late-stage programs into PPQ/ commercial biologics manufacturing.
The selected candidate as part of the Global MSAT Tech Transfer and Process Validation team is responsible for supporting the implementation of network alignment strategy and creation of global templates/documentation for Process Validation across JUST Evotec Manufacturing network. The team member will also provide support for new facility startup engineering runs, execution of performance qualification runs, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections.
*
* What You’ll Do:

*** Project Lead for Process Validation and/or Tech Transfer activities of late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
* Support technology transfer activities ensuring process gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
* In collaboration with cross functional teams, develop Process Validation Master Plans, provide process knowledge to support Process Characterization, and perform Process Validation risk assessments.
* Support development, review and approval of technical documentation including global protocols for Process Performance Qualification runs, Process Validation studies, and associated reports related to engineering, GMP and PPQ runs.
* Support the development and implementation of templates for Process Validation and Continued Process Verification strategies.
* Support the generation of governance policies and related SOPs for Process Validation
* Manage project-specific deliverables including but not limited to PVMP, PPQ protocols and supporting validation such as mixing, hold time studies, impurity clearance, extractables & leachables, filter validation etc.
* Support technology transfer activities ensuring process gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
* Support the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
** Who You Are:
*** Bachelor’s degree in engineering science or related program with 10+ years relevant experience or 8+ years of relevant experience with an MS.
* Proven experience in leading Process Validation activities for late-stage clinical manufacturing, PPQ campaigns/ commercial campaign support.
* Understanding of GMP concepts and Quality systems necessary to execute process validation activities.
* Experience developing and…