Manager Equipment Systems Validation
SEAGEN
 Bothell, WA

Summary:

Global Quality Systems Equipment Systems Validation Manager is responsible for establishing and maintaining corporate policies and procedures for the validation of GxP laboratory, manufacturing, and utility systems to comply with 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines. The manager will provide leadership across the Seagen network for alignment on equipment qualification practices. Additionally, the manager will lead the team of QA Validation professionals in charge of the validation lifecycle for operations and systems supporting GxP operations at the Seagen Canyon Park site.

Principal Responsibilities:

  • Provide subject matter expertise for qualification and validation of equipment, utilities, facilities, and laboratory instruments
  • Coordinate cross-site alignment and community of practice for equipment qualification discipline
  • Establish and maintain policies, procedures, and tools to ensure GxP systems are validated and controlled to comply with US and EU GMP regulations and ICH guidelines
  • Act as primary point of contact for the validation of laboratory, manufacturing, and utility systems and the Seagen Canyon Park site
  • Manage group projects and workload to support the validation lifecycle of GxP laboratory, manufacturing, and utility systems
  • Responsible for managing QA oversight of the equipment management program at the Canyon Park site to include equipment onboarding and calibration/maintenance programs
  • Work with senior leaders and managers of client departments to prioritize work and develop project timelines
  • Develop personal and team goals, partner with client departments for goals and plans
  • Develop, mentor, and train staff
  • Lead / facilitate the development of sound risk-based test strategies and plans
  • Gather and evaluate data for trending and monitoring of the validation process
  • Drives continuous improvement by monitoring metrics and implementing lessons learned
  • Provide validation support for audits and inspections, as needed
  • Support audits of system suppliers, acting as the validation SME
  • Lead complicated and or novel validation efforts, as required

Required Qualifications:

  • 2+ years prior management experience
  • 7+ years relevant GMP and/or validation experience
  • Strong working knowledge of system validation following industry standards (GAMP and ISPE), and cGMP is required, including ability to interpret and apply industry specific guidance's
  • Previous experience working with change management systems
  • Excellent written and verbal communication skills
  • Ability to proactively identify and implement continuous improvements
  • Proven ability to work effectively in a fast-paced team environment
  • Ability to organize information in a consistent and readily retrievable manner

Preferred Qualifications:

  • Prior QA experience
  • Previous audit experience
  • Involvement with industry groups such as PDA and/or ISPE

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.

Seagen 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.

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