Facilities Validation Engineer II

19 Mar 2023

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:

Seagen is seeking for a highly motivated Commissioning & Qualification Validation Engineer to focus on preparing and updating of test procedures documents, executing Factory Acceptance Test (FAT), Site Acceptance Test (SAT), commissioning activities, and IO/Q’s on equipment. The individual will qualify equipment, work with IO/Q documents, develop equipment protocols and generate reports. As part of a growing team, the employee will have an opportunity to improve/expand their pharmaceutical and bio-tech experience.

This position supports the validation team in the Commissioning & Qualifications of facilities and engineering equipment, within the qualification program. This position is responsible for performing periodic reviews and routine equipment validations. The position also supports the enrollment & commissioning, testing qualification of protocols.

The person will be responsible for assisting with GMP equipment and for creating, updating, and maintaining facilities & engineering qualification SOPs and work instructions. This position reports to the Sr. Engineering Manager Commissioning & Qualification.

Principal Responsibilities:

  • Using Good Engineering practice, enroll and commission equipment for qualification
  • Planning, prepping, and performing equipment qualifications and requalification for QC support labs
  • Conduct equipment training, communication, and escort of equipment validation contractors
  • Champion CRs and coordinating with QA and Facilities GMP technicians
  • Support C&Q validation exception investigations
  • Support C&Q facility & engineering departmental validation continuous improvement efforts
  • Revising and maintaining C&Q facility & engineering equipment procedures
  • Supporting C&Q facility & engineering projects
  • Creating and supporting engineering documents
  • Individual contributor for C&Q team
  • Ensure schedule is aligned department
  • Execute C&Q activities
  • Keeping informed team and manager of developments and improvements


  • Must have a minimum of 3-5 years’ experience with commissioning & qualification of equipment
  • Computer skills with different applications
  • Knowledge in mechanical, automation, and electrical troubleshooting (is preferred)
  • Previous experience working in a regulated biotech, pharmaceutical or health care industry required Must have demonstrated ability to effectively support operations in a GMP and/or GLP environment, preferably within the role of Facilities and Engineering
  • Occasional travel, up to 10%, may be required
  • Strong work ethic with high attention to detail and organization
  • The job has a possibility to work extended hours and weekend if necessary


  • Bachelor’s degree (B.S) in Engineering preferred, minimum of 2 years of relevant experience, or equivalent combination of education and working 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 $88,000 - $114,000 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.


  • ID: #49500944
  • State: Washington Bothell 98011 Bothell USA
  • City: Bothell
  • Salary: $88,000 - $114,000 a year
  • Showed: 2023-03-19
  • Deadline: 2023-04-04
  • Category: Science/biotech