Seagen

Quality Validation Sr Specialist

Technical Operations & Process Sciences - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Position Summary:

The Site Quality Validation Sr. Specialist is a seasoned experienced professional that collaborates with Facilities, Engineering, MSAT, Manufacturing, and other Quality experts to ensure the quality of products and compliance with internal standards, international regulatory expectations, and industry best practices. The Site Quality Validation Sr Specialist provides quality oversight and guidance of facility/utility, equipment, method, and process validation documents to support clinical and commercial manufacturing. In addition, the Site Quality Validation Sr. Specialist provides quality expertise for the standards and requirements for facilities, utilities, equipment, computer systems, cleaning, and processes. The incumbent is responsible for reviewing, editing and approving quality management system records (i.e., CAPA, change controls, SOPs, Reports, and other documentation. This role gives industry guidance and best practices in quality decisions related to elements of the qualification/validation lifecycle executed in support of site operations.

Principal Responsibilities:

• Support or serve as site Quality for one or more validation area:
• Primarily process validation (and review of process monitoring data for CPV), test method validation (and periodic review of validated test methods), cleaning validation.
• May also support shipping validation, equipment, utility, CSV.
• Develop, revise, and/or review SOPs associated with validation, as required.
• Review/collaborate and/or approve SOPs, validation plans, protocols, and/or reports, to support compliance with applicable SOPs and guidance.
• Develop, collaborate on validation master plans (VMPs), and VMP summary reports.
• Review and approve product validation plans, protocols, and reports.
• Provide quality validation support for internal GMP audits, as required.
• Participate in GMP regulatory and QP inspections, as required.
• May provide expertise and guidance in interpreting existing and emerging governmental regulations, agency guidelines and internal policies to assure compliance.
• Perform change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state.
• Support review and approval of deviations/incident handling to assess impact on validation, and support development of compliant resolutions, as needed.
• Provide data integrity support to site and partner with corporate data integrity group.
• Review CMC sections of NDA/BLA and perform quality review of CMC sections, as needed.

Required Qualifications:

• BS/BA with 8+ (Specialist) 10+ (Sr. Specialist) years relevant GMP and validation experience
• Strong working knowledge of validation (process/system) following industry standards (GAMP, ISPE, ICH), and cGMP is required, including ability to interpret and apply industry specific guidance's
• Working knowledge of process validation, process characterization, technology transfer and continued process verification
• 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 facility experience
• Previous audit experience
• Data Integrity 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.

The hiring pay range for this position is $103,000 to $133,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/10/2023