Senior Manager, Commissioning & Qualification - Launch Pad

Corporate Functions 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:  

Seagen’s new cGMP manufacturing facility ‘Launch Pad” is being built close to Seattle, Washington USA. Launch Pad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs), breaking ground in the near future. 

The Commissioning and Qualification Sr. Manager serves as a site functional manager and resource for the commissioning and qualification activities supporting facility and utility equipment.  The incumbent will resolve technical and process challenges in a regulated GxP environment.  This person will, on occasion draft, review and execute documents and procedures related to guidance and controlled documents as necessary. This individual will also utilize C&Q experience and expertise to draft, review, and execute documentation and activities.  As the Commissioning and Qualification Sr. Manager, the professional will lead a team of commissioning and qualification engineers per schedule and in alignment with GMP compliance and Quality Assurance Requirements. 

 
Principal Responsibilities: 

  • Proven track record of Audit Preparation and Readiness with Quality, Compliance and Safety 
  • Proven knowledge of applying Risk Based Approach for C&Q activities within the biotechnology industry 
  • Accountable for C&Q activities supporting the site Facility and Utility equipment 
  • Reviews and Approves plans, test documents, overall project strategy and protocol summaries
  • Manages and supervises related C&Q activities 
  • Ensures the C&Q schedule(s) are developed, monitored and controlled
  • Manages and ensures GMP training of all engineers and compliance personnel who deliver C&Q actions 
  • Manages risk, concerns and issues for tiered escalation from the site to the management as required 
  • Ensures Good Documentation and Good Engineering Practices, GDP and GEP 
  • Partner as a Leader within the site Cross Functional Team to support site operations and C&Q daily responsibilities 
  • Responsible to review technical requirement specifications and project documentation supporting C&Q protocols such as URS, FS, P&IDs, Isometrics, FAT, SAT, Installation and Operation Commissioning tests, IQ and OQs 
  • Ensures adherence and compliance to pre-start up safety checks, LOTO and site safety programs 
  • Functional area participant to support C&Q deliverables such as system impact assessments, establishing system boundary drawings, traceability matrix 
  • Manage oversight of 3rd party organizations with inspections, document redline, review of C&Q supporting documentation 
  • Participate in change controls, deviations, investigations, corrective/preventive actions, root cause analysis to drive timely close out  

 Required Qualifications: 

  • Bachelor of Science, Mechanical, Chemical, Electrical Engineering, or equivalent technical training plus 10+ years related experience  
  • 7+ years experience within GxP environment 
  • 5+ years experience in Commissioning and Qualification or Engineering Management 
  • Demonstrated knowledge of GMP industry regulations 

 Preferred Qualifications: 

  • American Society of Quality Certification or equivalent 
  • RAPS Certification 
  • GMP Certification  

 

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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