This position supports the validation team and maintains North Creek & Facilities qualification program. This position is responsible for leading and performing equipment validation projects for Seattle Genetics, Inc. This position supports equipment qualification by coordinating GxP equipment enrollment & commissioning, reviewing and approving equipment qualification protocols and reports. Responsible for creating, updating and maintaining Facilities qualification SOPs and work instructions.
This position reports to the Manager of Facilities Compliance
Using Good Engineering practice, enroll and commission equipment for qualification
Planning, prepping and performing equipment re-qualifications for manufacturing operations
Plan and Execute complex equipment/utility IQPQs
Champion CRs and coordinating with QA and Facilities GMP technicians
Conduct equipment validation training, communication, and escort of equipment validation contractors
Support validation exception investigations
Champion equipment validation Continuous improvement efforts
Revising and maintaining equipment validation procedures
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Networks with key contacts outside own area of expertise
Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead)
Passion for Continuous Improvement (CI)
Effective team player and strong communicator
Ability to self-start and direct activities in the absence of supervision
Typically requires a university degree and a minimum of 5-10 years of related experience
Introductory and annual refresher GMP Training
Specific On the Job training as assigned
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 www.seattlegenetics.com.
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.