Seagen

Senior Validation Engineer CSV

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 Sr. Validation Engineer is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to the manufacture of all Seagen products, whether manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent will be part of a validation team which is responsible for the end-to-end validation processes. Specifically, this role has responsibility for developing and delivering computer system validation solutions to manufacturing equipment and equipment validation programs to ensure compliance with applicable cGMPs and global health authority regulations. The Sr. Validation Engineer partners with Manufacturing, Quality, Regulatory and IT to develop validation plans and ensure their execution and lifecycle management. The holder of this position is likely to be a subject matter expert in one or more aspects of validation.

Principal Responsibilities:

• Develop and share validation expertise and scientific understanding of key Pharmaceutical Operations. Is a subject matter expert in validation approaches (e.g., Computer System validation, equipment, and risk-based approaches) and apply this understanding to ensure Product Supply manufacturing operations are maintained in a constant state of compliance
• Executes, and provides guidance/oversight for site validation of CSV, equipment and technologies, and modifications of existing systems
• Contributes towards the management and maintenance of processes/procedures defined in the system development life cycle (SDLC) and Computer Systems Validation (CSV)
• Develops, executes, and documents validation programs for equipment (both internally and for externally manufactured products)
• Develops risk-based approaches to revalidation of equipment software, equipment, and technologies relating to GMP manufacturing
• Support products throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification)
• Develops and leads Validation Master plans, in collaboration with manufacturing sites (both Internal and External) and Quality and Regulatory functions
• Develop project plans for validation activities and ensure plans are delivered
• Leads the CSV validation activities as part of the new facility/process design, build and qualification
• Shares best practice in computer system validation and associated disciplines
• Interfaces with multiple sites and departments (i.e., Internal and external (CMO’s) Manufacturing, Quality & Regulatory) to deliver best practice validation packages
• Proactively engages with Manufacturing sites/Development and QA and advocates the use of QbD principles for facilities, utilities, and equipment
• Responsible for expanding and continuously updating a validation and regulatory knowledge base. Advise on validation and risk-based approaches
• Develops Standards, Guidelines and SOPs 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

Qualifications:

• Extensive technical knowledge of validation and current validation approaches and practice
• Excellent knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations, and standards
• Strong working knowledge of computerized system validation following industry standards (GAMP), and cGMP is required, including ability to interpret and apply ICH guidance and regulatory guidance
• Experience with processes such as Change & Configuration Management
• Experience of fronting regulatory inspections on validation
• Experience with validation of biologics and sterile facilities
• Experience with equipment, computer systems validation
• Experience working with Contract Manufacturing Organizations
• 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
• The ability to influence and work across organizational boundaries
• Strong communication skills and computer literacy are essential
• Experience delivering technology projects
• A good understanding of statistical analysis and continuous process verification is desirable

Education:

• Bachelor’s degree in Industrial Pharmacy, Pharmaceutical Sciences, Chemistry, Mechanical/Civil/Chemical engineering, or another relevant life-science discipline with a minimum of 10 years of industrial experience in validation practices and approaches.
• Alternatively, a Masters’ degree with a minimum of 8 year's experience or a PhD degree with minimum 6 years of industrial experience.

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 $121,000 to $156,200 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: 10/14/2022