Validation Engineer II - Site Based, Redmond, WA

Cyprotex • Redmond, WA

10d • Onsite

About The Position

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.

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

Nice To Haves

• 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.

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

Benefits

• 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 options to help you balance your professional and personal life.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level