AGC Biologics · 8 hours ago
Validation Engineer III
Bothell, Washington, USA
Full-time
Onsite
Mid, Senior Level
$94K/yr - $129K/yr
6+ years expAGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization committed to delivering the highest standard of service. The Validation Engineer III will support qualification and validation of facilities, utilities, equipment, and systems in the manufacture of cGMP protein-based therapeutics, while ensuring compliance with regulatory standards.
BiotechnologyIndustrialManufacturing
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
Qualification
Required
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
Company
AGC Biologics
AGC Biologics is a global Contract Development and Manufacturing Organization with a commitment to deliver the highest standard of service.
1001-5000 employees
H1B Sponsorship
AGC Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (2)
2023 (4)
2022 (6)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Patricio Massera
CEO
Amy Lee
Senior Human Resources Business Partner
Recent News
Genetic Engineering News
2026-01-16
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