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Senior Process Validation Engineer

companySeagen
locationBothell, WA, USA
PublishedPublished: 12/8/2023
Full Time

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 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 externally 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 process and cleaning validation solutions to manufacturing processes and validation programs to ensure compliance with applicable cGMPs and global health authority regulations. The Sr. Validation Engineer partners with Manufacturing, Quality, Facilities, 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: 

  • Support products throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification) 
  • Executes, and provides guidance/oversight for validation activities pertaining to Process Validation, Cleaning Validation, Continued Process Verifications (CPV), and improvements of existing/legacy qualifications at the site/global level 
  • Contributes towards the management and maintenance of processes/procedures defined in the Process Validation and Cleaning Validation programs 
  • Interfaces with multiple sites and departments (i.e., Internal, and external (CMO’s)  
  • Responsible for expanding and continuously updating their validation and regulatory knowledge base and sharing their expertise and scientific understanding of key pharmaceutical operations 
  • Support as a subject matter expert in one or more validation areas (e.g., Process Validation, Cleaning Validation, or Continued Process Verification) 
  • Provides data management and analytics expertise required to support MSAT and Seagen manufacturing, both internal and external across all product modalities 
  • Develops risk-based approaches to revalidation of processes, cleaning, and technologies relating to GMP manufacturing 
  • Develops and leads Validation Master plans, in collaboration with MSAT, Development, Quality and Regulatory functions at different manufacturing sites (both Internal and External) 
  • Develop and lead project plans for validation activities and ensure plans are completed on schedule 
  • Conduct data analyses in support of MSAT responsibilities by leveraging a variety of analytics approaches to deliver data and information for investigations, trending, anomalies or deviations, root cause analyses, etc. 
  • Leads, develops, executes, and documents validation activities for process, cleaning, and CPV (both internally and for externally manufactured products) 
  • Proactively engages with Manufacturing sites/Development and QA and advocates the use of QbD principles for facilities, utilities, and equipment 
  • Advises on validation and risk-based approaches and can apply their understanding to ensure Product Supply manufacturing operations are maintained in a constant state of compliance 
  • 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 
  • Experience with manufacturing data management and analysis is desirable 
  • Strong working knowledge of industry standards relating to Process and Cleaning Validation is required, including ability to interpret and apply ICH guidance and other regulatory guidance as required 
  • Experience in defending validations during regulatory inspections or audits 
  • Experience with validation of biologics and sterile facilities 
  • Experience with process equipment, and equipment used for cleaning (i.e., CIP systems, parts washers) 
  • 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 statistics, statistical analysis, process validation, and continuous process verification 

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 years’ 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 $123,000 to $160,000 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 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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