Validation Engineer II - Site Based, Redmond, WA

Responsibilities

• 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

Requirements

• Bachelor's 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 : We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.
• Flexible Work Environment : We offer flexible work op

Benefits

Additional Information

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 what's possible. We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious 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 Validation Engineer II 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 Validation Engineer II 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 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.

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