Job Description

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.

We are seeking a Manager, Validation to lead and oversee validation activities and Validation Quality Systems for site‑level GMP systems. This role is responsible for ensuring the effective planning, execution, and governance of validation deliverables in accordance with global regulatory requirements.

The Manager, Validation supports timely completion of validation documentation, drives continuous improvement initiatives, and serves as a subject matter expert for validation and electronic data integrity. This role partners closely with Manufacturing, Engineering, IT, Quality, and external vendors, and plays a key role in supporting regulatory inspections. The position also provides leadership, coaching, and development for members of the Validation team.

About Our Validation Team

You’ll join a dedicated Validation Team responsible for ensuring GMP systems are fit for intended use, compliant, and inspection‑ready. The team works cross‑functionally with operational and technical partners to support a growing and increasingly complex environment. Our approach emphasizes risk‑based validation, strong technical knowledge, and continuous improvement. The environment is fast‑paced, highly collaborative, and focused on delivering compliant, business‑ready solutions.

Your Key Responsibilities

• Lead and support the completion of GMP validation documentation for site systems, ensuring milestones and deliverables are met on agreed timelines.

• Oversee the implementation and maintenance of Validation Quality Systems, including policies, procedures, guidance documents, training, and tools.

• Monitor and maintain controls, procedures, and guidance that define and align validation activities for both internal and external GMP systems.

• Drive continuous improvement initiatives to enhance efficiency, effectiveness, and consistency of validation operations.

• Serve as a subject matter expert for validation practices and electronic data integrity requirements.

• Partner with cross‑functional stakeholders including IT, Engineering, Manufacturing, Quality, and external vendors to support validation activities.

• Support regulatory inspections and audits related to validation and computerized systems.

• Provide coaching, performance feedback, and professional development to Validation team members.

• Ensure validation strategies and execution align with FDA, EMA, and other global health authority expectations.

Your Qualifications & Experience

Required:

• Bachelor’s degree (BS/BA) with 8+ years of relevant industry experience, or Master’s degree with 6+ years of relevant experience. Equivalent education and experience may be considered.

• Demonstrated experience in GMP validation within a regulated pharmaceutical or life sciences environment.

• In‑depth knowledge of global regulatory expectations related to validation, computerized systems, and electronic records.

• Demonstrated subject matter expertise in validation and IT systems compliance as defined by pharmaceutical regulatory authorities.

• Hands‑on experience with cloud‑based and service‑based system validation and Computer Software Assurance (CSA), including systems such as ERP, LIMS, and QMS.

• Ability to work flexible hours as needed to support network and operational requirements.

Preferred Skills & Competencies:

• Strong facilitation and project management skills with the ability to manage multiple priorities.

• Excellent written and verbal communication skills.

• Strategic understanding of validation lifecycle activities and electronic record/data integrity requirements.

• Exceptional stakeholder and customer interface skills.

• Proven ability to lead, coach, and develop validation professionals.

Formalities

Location: Bothell, WA

Schedule: Full‑time, onsite

Compensation Range $108,080 - $148,610

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; 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.