Validation Engineer

Technical Operations & Process Sciences Bothell, United States


Description

Position at Seagen

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 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 equipment and process validation programs to ensure compliance with applicable cGMPs and global health authority regulations. The 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 validation expertise and scientific understanding of key Pharmaceutical Operations. Is a subject matter expert in validation approaches (e.g., Cleaning Validation, Computer System Validation, Process/Technology validation, CPV, risk-based approaches) and apply this understanding to ensure Product Supply manufacturing operations are maintained in a constant state of compliance 
  • Develops, executes and documents validation programs for processes and manufacturing equipment (both internally and for externally manufactured products) 
  • Support products throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification) 
  • Assists with the development of 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 
  • Executes and provides guidance and oversight and for site validation of new products, technologies and modifications of existing formulations and processes 
  • Develops risk-based approaches to revalidation of products, processes and systems 
  • Leads/supports the validation activities as part of the new facility/process design, build and qualification 
  • Shares best practice in process/equipment validation and associated disciplines 
  • Interfaces and collaborates with Development/Process Sciences, MS&T SME’s, Manufacturing, Quality and Regulatory teams to develop robust plans for qualifying, and trending Critical Process Parameters, Critical Quality Attributes) 
  • 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 to define Critical Process Parameters (CPP’s) and the implementation of Continued Process Verification (CPV). Supports ongoing CPV programs 
  • Responsible for expanding and continuously updating a validation and regulatory knowledge base. Advises on validation and risk-based approaches 
  • Assists with the development of 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 
  • Good knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations and standards 
  • Experience in managing validation programs in support of GxP Operations (Equipment and Process) 
  • Experience of fronting regulatory inspections on validation 
  • Experience with validation of API, OSD, Parenteral and Biologics formulations and facilities. 
  • Experience of facility, equipment, process, cleaning and continuous process verification 
  • 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 
  • Fluency in spoken and written English is mandatory 
  • A good understanding of statistical analysis and continuous process verification is desirable 

Education: 

  • Bachelor’s degree in Industrial Pharmacy, Pharmaceutical Sciences, Chemical engineering, or another relevant life-science discipline with a minimum of 8 years of industrial experience in validation practices and approaches. Alternatively, a Masters’ degree with a minimum of 6 years' experience or a PhD degree with minimum 4 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.   

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.   

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 


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