Validation Engineer III

Location: Bothell

Validation Engineer III page is loaded## Validation Engineer III locations:
Bothell, Washington, USAtime type:
Full time posted on:
Posted 2 Days Agotime left to apply:
End Date:
February 19, 2026 (18 days left to apply) job requisition :
JR102701
** Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
**** Job Summary
** We are looking for a Validation Engineer III to support qualification and validation of facilities, utilities, equipment, analytical systems, and computerized systems used in the manufacture of cGMP protein-based therapeutics, including cell and gene therapies. This role plays a key part in ensuring systems remain compliant, inspection-ready, and aligned with regulatory and quality standards.

The Validation Engineer III partners closely with Engineering, Operations, Quality, and customer project teams to execute validation strategies, support continuous improvement, and maintain a strong state of compliance across the site.

Location:

Bothell, WA

Schedule:

Onsite, Monday - Friday  Compensation: $94,000 – $129,250
** Key Responsibilities
*** Lead and execute equipment, facility, utility, and system validation activities.
* Prepare and execute IQ/OQ/PQ protocols for manufacturing equipment, analytical instruments, facilities, and utilities (e.g., HVAC, BAS, compressed air, nitrogen).
* Support commissioning and engineering studies related to new and existing systems.
* Generate and review qualification reports and validation documentation for internal and regulatory use.
* Manage requalification activities in support of change control.
* Initiate and support deviations, change controls, and CAPAs related to validation activities.
* Develop and maintain validation traceability matrices and GMP criticality assessments.
* Analyze validation data and ensure documentation meets Good Documentation Practices and regulatory requirements.
* Partner with Quality, Engineering, and Operations to define validation strategies and ensure inspection readiness.
* Support investigations and risk assessments related to equipment and process validation.
* Identify and propose remediation for validation gaps or compliance risks.
* Provide validation and quality expertise to internal teams and customer projects.
** Qualifications
* ** Bachelor’s degree with 8+ years of relevant validation experience, or Master’s degree with 6+ years of relevant experience.
* Experience validating facilities, utilities, equipment, and computerized systems in a cGMP environment.
* Strong knowledge of GMP, ICH, and ISO requirements.
* Experience with change control, deviations, investigations, and CAPA processes.
* Experience supporting regulatory inspections and audits.
* Strong organizational, communication, and problem-solving skills.
* Ability to manage multiple priorities in a fast-paced, regulated environment.
* Collaborative, team-oriented mindset with attention to detail.
*** Our culture at AGC Biologics is defined by the six core values:
Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
****** AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington;
Boulder and Longmont, Colorado;
Cope…