Principal Validation Engineer MSAT

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 Principal Validation Engineer, MSAT is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to the manufacturing of our Seagen products, whether manufactured internally or externally at our contract manufacturing organizations (CMO’s). The incumbent leads, coordinates and collaborates with peers from different Validations functions to ensure that the validation strategies implemented are in alignment with Seagen validation policies, programs and best practices and are robust and well understoodThe MSAT Principal Validation Scientist/Engineer will have a leadership role in technology transfers, process, equipment, facility/utility validation and GMP manufacturing technical supportThe 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 GMP utilities, equipment, and process validation programs to ensure compliance with applicable cGMPs and global health authority regulations.  The Principal Validation Scientist/Engineer will provide technical and validation guidance as subject matter expert (SME) relating to cGMP manufacturing processes, change control, validation studies, technology implementation projects and process optimization. The incumbent shares his knowledge and supports and mentors Scientists, Engineers and Research associates. 

The Principal Validation Scientist/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: 

  • The technical lead who develops and shares validation expertise and scientific understanding of key Pharmaceutical Operations 
  • Considered a subject matter expert in different validation approaches (e.g., Facility, Utility, Equipment, Process & Cleaning validation, risk-based approaches etc) and can apply this understanding in a manufacturing setting    
  • Provides technical and scientific leadership as subject matter expert (SME) relating to technology transfers, manufacturing processes, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process optimization 
  • Acts as the primary technical lead for validation activities on new facility/process design, build and qualification   
  • Leads, develops, executes, and documents validation programmes for facilities/utilities and equipment (both internally and for externally manufactured products) 
  • Support products throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification) 
  • Leads and develops Validation Master plans, in collaboration with Manufacturing, Quality, and Regulatory functions  
  • Develops project plans for validation activities and ensures plans are implemented and adhered to 
  • Executes, provides guidance, and oversight for site validation of facilities/utilities, equipment, process, and technologies including modifications of existing systems  
  • Interfaces and shares with multiple sites and departments to deliver best practice validation packages in utility/equipment/process/cleaning validation and associated disciplines 
  • Develops risk-based validation approaches for our products, processes, and systems 
  • Proactively engages with Manufacturing sites/Development and QA and advocates the use of QbD principles for facilities, utilities, and equipment 
  • Works cross-functionally supporting Development and Manufacturing to develop validation plans and approaches, including novel process technologies and facility expansions/modifications to maintain state-of-the-art production capability 
  • Responsible for expanding and continuously updating a validation and regulatory knowledge base. Advises on validation and risk-based approaches 
  • Has a leadership role in the development of Standards, Guidelines, SOP’s, and templates to enhance the quality and robustness of our validation processes, manufacturing operations, knowledge transfer, and technical support processes 
  • Interfaces with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes 
  • Identifies and initiates validation process and procedural changes to improve validation and process performance, robustness, productivity, safety, efficiency, and compliance 
  • Supports and mentors Scientists, Engineers 

Required Qualifications 

  • Strong scientific and technical experience within relevant manufacturing process technologies and unit operations 
  • Strong technical knowledge of validation and current validation approaches and practice 
  • Working knowledge of pharmaceutical standards, regulations, current industry practices, and experience with interpretation and application of guidelines, regulations, and standards such as ICH guidelines, Q7-12 
  • Experience with validation of biologics and sterile facilities 
  • The ability to influence and work across organizational boundaries 
  • Experience with cross-functional/matrix project or team leadership 
  • The ability to work effectively and lead small matrix and cross-functional 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 
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships 
  • Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seagen 
  • Working knowledge of cGMP is required, including ability to understand and apply regulations, guidance’s, and industry best practices to area of responsibility 
  • Experience with managing validation programs at a site including facility, utilities, equipment, and electronic systems used within the pharmaceutical or biopharmaceutical industry 
  • Experience in managing validation programs in support of GxP Operations (e.g., Facility/Utilities and Equipment, Cleaning, Computer Systems Validation and Continuous Process Verification) 
  • Detail oriented with strong organizational, time, and project management skills 
  • Experience participating in regulatory inspections 
  • Strong communication skills and computer literacy are essential 
  • Experience with innovation and operational excellence is desirable 

 Preferred Qualifications 

  • Green field experience and proven experience in building and developing high performing validation programs 
  • Bachelor’s degree in Chemistry, Industrial Pharmacy, Pharmaceutical Sciences, Mechanical/Civil/Chemical engineering, or another relevant life-science discipline 
  • Working knowledge of cGMP is required, including ability to understand and apply regulations, guidances and industry best practices to area of responsibility  
  • Experience in regulatory inspections defending validation packages and defense strategy preparation 
  • Experience with commercial cGMP manufacturing 
  • Experience working with Contract Manufacturing Organizations 
  • A good understanding of statistical analysis and continuous process verification is desirable 

Education: 

  • Bachelor’s degree in Chemistry, Industrial Pharmacy, Pharmaceutical Sciences, Mechanical/Civil/Chemical engineering, or another relevant life-science discipline with a minimum of 12 years of industrial experience in validation practices and approaches 
  • Alternatively, a Masters’ degree with a minimum of 10 years' experience or a PhD degree with minimum 8 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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