Validation Engineer III

AGC Biologics•Bothell, WA

1d•$94,000 - $129,250•Onsite

About The Position

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. 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; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life-changing – and in some cases – life-saving drug products.

Requirements

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.

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.