Associate Director Validation Leader

Product Supply Operations Bothell, Washington



The Validation Leader is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to the manufacturing of all Seattle Genetics products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent is an expert and has extensive knowledge of Validation and plays a pivotal leadership and coordinating role for the end to end validation process. This role leads and oversees Product Supply’s facility, equipment and process validation programs and partners with IT in the Computer Systems Validation (CSV) for manufacturing processes, equipment & facilities. The Validation Leader develops global strategies and standards to ensure manufacturing facilities and processes are validated and maintained in a state of compliance with applicable cGMPs, global health authority regulations and industry standards. The Validation Leader partners with Manufacturing, MSAT, Development/Process Sciences, Quality, IT and Regulatory and EHS to manage the development of the master validation plans, their execution and lifecycle management.

Principal Responsibilities:

  • Leads, develops and implements the Product Supply’s validation policies and procedures based on current regulations, industry standards and best practices
  • Leads and oversees Product Supply’s facility (building, utilities and services), equipment and process validation programs
  • Provides technical oversight of validation systems, standards and documentation supporting new drug applications, product launches, technology transfers, facility and equipment modifications/upgrades, and modifications to existing formulations and processes
  • Utilizes a risk-based approach to develop and maintain compliant, and cost-effective systems and procedures. Develops and supports procedures including Statistical Process Control and Continued Process Verification to enable robust and compliant manufacturing
  • Collaborates with IT and Quality to ensure the validation of computer systems used across GXP operations is conducted in compliance with applicable regulatory requirements and internal procedures
  • Provides technical direction and guidance to all staff involved in validation activities (facility, equipment, process, CSV and cleaning). Mentors, trains, and develops future leaders in validation and associated disciplines
  • Interfaces with collaborates with Development/Process Sciences, MS&T SME’s, Manufacturing and QA teams to develop robust systems for identifying, challenging, qualifying, and trending Critical Process Parameters, Critical Quality Attributes, Control Strategies, and Sampling and Testing Plans
  • Builds and maintains expertise in validation and related activities. Acts as a subject matter expert in discussions and communications with regulatory agencies including activities associated with regulatory submissions and facility inspections
  • Reviews and provides guidance on proposed changes to validated processes via CAPA and Change Controls to assess risk and identify requirements necessary to maintain a validated state
  • Assists with the development of Standards, Guidelines and SOP’s to enhance the quality and robustness of our manufacturing operations, knowledge transfer and technical support processes
  • Works cross-functionally supporting Development and Manufacturing as well as CMO’s to develop validation plans and approaches, including novel process technologies and facility expansions/modifications to maintain state-of-the-art production capability
  • Coaches and shares knowledge across Technical Operations


  • Extensive technical knowledge of validation and current validation approaches and practice
  • Validation Leadership experience (team leadership, functional or discipline leadership)
  • Extensive knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations and standards
  • Proven track record with successfully managing validation programs in support of GxP Operations (Facility, Equipment and Process)
  • Experience of fronting regulatory inspections on validation
  • Experience with validation of API, OSD, Parenteral and Biologics formulations and facilities
  • Experience with Sterile facility (clean room (ISO 8), water for injection, other support utilities etc) validation
  • Experience of facility, equipment, process, cleaning, computer systems validation and continuous process verification
  • Experience working with Contract Manufacturing Organizations
  • Good leadership skills and ability to influence and work across organizational boundaries
  • The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
  • Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seattle Genetics
  • The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally
  • Strong communication skills and computer literacy are essential
  • Fluency in spoken and written English is mandatory
  • A good understanding of statistical analysis and continuous process verification is desirable


  • Masters’ degree in pharmaceutical science or another relevant life-science discipline with15 years of industrial experience in validation practices and approaches. Alternatively a PhD degree with 12 years of experience

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.