Specialist Quality Control Equipment

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 purpose of this position is to oversee the lifecycle management of all Quality Control (QC) instrumentation and related software systems. This role will be the liaison between QC laboratory and Facilities, IT, Validation, and QA departments to support QC equipment and associated software implementation and maintenance. This position supports equipment management operations to ensure instruments are validated, and available for use for QC sample testing in accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory. 
 
Principal Responsibilities 

  • Ensure equipment is managed in accordance with governing procedures and regulations. 
  • Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner 
  • Take lead role and launch change control records for document and/or equipment changes 
  • Coordinate with Facilities for scheduling calibration, maintenance, and repairs 
  • Support new and upgraded instrument software by working with IT in writing/revising, executing, and reviewing software validation test scripts as needed 
  • Perform periodic reviews of equipment and software as the System Owner 
  • Arrange purchases and receipt of new equipment 
  • Perform data integrity and impact assessments for equipment and associated software.  
  • Represent QC in cross-functional project teams 
  • Participate in regulating agency inspections, internal audits, and partner audits. May participate as subject matter expert (SME) 
  • Apply the principles of good manufacturing practices (GMP) on a daily basis 
  • Create and revise standard operating procedures (SOP’s) and other documents as needed 
  • Identify and lead continuous improvement projects 
  • Maintain training to current standards and procedures on all assigned curriculums 
  • Fully comply with company health and safety procedures and practices 
  • Author and own deviations and CAPAs 
  • Train and mentor other personnel 
  • Support other equipment System Owners as needed 
  • Address equipment alarms such as for temperature excursions including moving material to alternate storage unit, performing investigations into the cause for the excursion and assessing impact of the temperature excursion 
  • A few hours of evening, weekend, and/or on-call work may be occasionally required to address equipment alarms 

Required Qualifications: 

  • Bachelor’s degree or associates degree and 2+ years in relevant field 
  • 5+ years relevant experience 
  • Experience using or managing analytical lab equipment (spectrophotometers, titrators, pH meters, CEs, balances, HPLCs, etc.) 
  • Experience authoring standard operating procedures 
  • Experience performing instrument and software validation 
  • Be highly organized with an attention to detail 
  • Ability to keep order of multiple projects/tasks 

Preferred Qualifications: 

  • BS/BA degree in biological, chemical, or engineering sciences preferred 
  • GxP experience 
  • Experience using potency testing instrumentation (plate readers, liquid handling robots, biological safety cabinets, etc.) 
  • Experience using a Laboratory Information Management System (LIMS) 
  • Experience with Blue Mountain, Maximo, or other equipment maintenance management system 

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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