Seagen

Senior Quality Assurance Validation Specialist - Launchpad

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!

Summary:

The Quality Validation Sr Specialist is responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of GxP laboratory, manufacturing, CSV, and facility/utility systems to comply with 21 CFR Part 11, 210 and 211, Eudralex regulations and ICH guidelines. The Sr. Specialist will work within the Quality Validation organization which is responsible for quality oversight of the execution of validation and qualification protocols and reports as they apply to Launch Pad facilities, utilities, equipment, computer systems, cleaning, and processes. The Sr. Specialist will support facility start-up activities, technical transfers, FAT, re-qualifications, and routine activities as they pertain to Laboratories, Manufacturing, Facilities, Maintenance and Warehouse functions. Additionally, the Sr. Specialist will be responsible for implementing program improvements to align with current industry best practices.

Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).

The Sr Specialist will be closely involved in the facility design and construction phases, as well as commissioning/qualification/validation (CQV) and start-up planning. The incumbent will join the quality validation team and support systems during the construction and CQV phases to enable on-time successful facility start-up. The ideal candidate has validation and/or quality experience for antibody and sterile drug product manufacturing. Prior experience with a facility start-up or expansion is key, and a strong background in oversight of CSV is preferred. The candidate should also have an established track record for successfully supporting validation activities at clinical and commercial manufacturing organizations.

People management responsibility is possible for a limited number of junior staff.

Principal Responsibilities:

• Provide Quality Oversight on validation projects for simple to complex systems and/or projects to assure systems are fit for purpose in GMP operations, including:
• Support customer groups and junior staff by resolving complex technical issues supporting a range of projects
• Perform impact assessments on and approve system change controls
• Collaborate on or approve validation lifecycle documentation for small to large systems
• Collaborate on or approve system operation, administration, and use operating procedures
• Perform or approve investigations on deviations and incidents in small to large systems
• Lead or participate in the successful completion of cross-functional projects
• Write/revise and collaborate on Quality directives, and approve standard operating procedures that impact multiple departments or programs based on industry best practices
• Participate as an SME in audits and inspections independently, as needed
• Represent Quality Systems on cross-functional teams or teams with external parties
• Lead continuous improvement activities that may involve a team
• Make independent decisions within the areas of expertise, with support from management on more complex issues
• Supervise entry-level associates Review staff training assignments Other duties as assigned

Required Qualifications:

• 8+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
• Bachelor's degree in relevant field; or Associate’s degree +2 years of relevant experience in the biotech or pharmaceutical industry
• Strong background of cGMP requirements is required, including ability to interpret and apply industry specific guidance documents
• Familiarity of system validation requirements and industry standards (GAMP and ISPE)
• Experience with cGMP facility start-up (commissioning and qualification)
• Advanced expertise with Office 365, especially Excel
• Previous experience working with quality management systems (change control, eDMS, event reporting, CAPA)
• Excellent written and oral communication skills
• Ability to proactively identify and implement continuous improvement projects
• Demonstrated problem-solving skills and techniques commensurate with job level
• Ability to manage routine and non-routine workload with little-to-no routine oversight
• Ability to organize information in a consistent and readily retrievable manner
• Proven ability to work effectively in a fast-paced team environment

Preferred Qualifications:

• Prior experience with greenfield projects
• Strong background in CSV oversight including implementation of complex systems (BAS, DCS, MES, LIMS, etc.)

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 $107,000 to $139,000 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: 05/26/2023