29 days old

Associate Director Automation

Seagen
Bothell, Washington 98021
  • Job Type
    Employee

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 Site Associate Director Automation serves as the REF technical lead resource for control systems, equipment and processes within Seagen – North Creek site.  This leader will support building facilities and manufacturing plant operations.  The incumbent will resolve technical, process challenges and manage site risks related to automation and IT.  The Lead should have the ability to plan, development, implement and train personnel on procedures, processes and protocols within the regulated environment.  Lead automation validation activities to support site investments and growth.  This position will serve as a coach to lesser experienced personnel to develop the REF talent pipeline as well as develop long term strategies to support the site’s goals and objectives. With the support of a team of automation engineers and contractors provide vast support to regulatory agency audits as well as site improvement projects. 

Principal Responsibilities: 

 

  • Subject Matter Expert, SME, and System Administrator of the Computerized Maintenance Management System (CMMS), Process Automation System (PAS) and Building Automation System (BAS) for manufacturing operations, lab environments/equipment, and office spaces 
  • Familiarity, knowledge, and experience with Instrumentation 
  • Responsible Lead to ensure compliance with Data Integrity principles 
  • Partner with Corporate Security for site Access Control and Security Equipment 
  • Maintain and troubleshoot computer and networking issues in relation to SCADA and DCS systems 
  • Lead Automation Engineers/technicians and contractors as required to execute the site automation strategy 
  • Identification and Management of risks related to automation and IT systems 
  • Lead innovations by implementing new methods and technologies which drive growth in digital data and analytics (DD&A) such as Power BI and any other Process Automation Bots 
  • Participant in the Site Capital Planning process 
  • Manage and report facility operation leading and lagging metrics/indicators to support site maintenance program – preventive and predictive maintenance 
  • Provide Automation and IT input to support the site Recapitalization Program and Facility Master Plan 
  • Develop mid to long term controls strategies 
  • Navigates business complexity interacting with IT, Validation and other REF members while developing compliant automation solutions 
  • Design, modify, and run reports from electronic systems that provide end users with data for both business and regulatory needs 
  • Ensure redline system and process drawings to reflect changes made to wiring, process, and system changes 
  • Use internal quality systems to generate, assess, and close Change Control, Deviation, and CAPA records 
  • Lead automation representative to work with Quality Assurance and other compliance groups to create, review, and execute validation protocols 
  • Lead due diligence activities against Industry and company Engineering Standards for automation, calibration and IT systems 
  • Support site Safety Culture and implement plans to reduce risk of identified gaps against EHS SOPs and Standards 
  • Support site gap assessment against Seagen Engineering Standards 
  • Experience working with process historians (Wonderware Historian, iHistorian, Pi, or similar) including administration and processing of live and historical data for trend, alarm, and batch reports 
  • Clear understanding of Industry knowledge such as ISPE, ISA symbols and terminology in relation to system loop diagrams and P&ID drawings 
  • Expert understanding of S88, S95 and batch processing operations required 
  • Strong practical understanding of Virtual systems 
  • Knowledge of Cybersecurity, patching and IT Life Cycle Management (LCM) 
  • Practical application of Backup systems for operational technology. (Avamar, Acronis, Etc) 
  • Experience using an Enterprise Asset Management system (Maximo) to track and record, log the status of work performed 
  • Ability to analyze and repair highly complex interconnected automation process control systems 
  • Strong understanding of ladder logic, function block, and structured text-based programming in relation to programmable controllers 
  • Familiarity with SCADA systems and concepts such as Allen Bradley Factory Talk, Siemens WinCC, Wonderware, iFix or similar systems 
  • Strong computer and controls networking background including Ethernet and control systems communications (BACNET, MODBUS, EtherIP, ProfiBUS) 

Required Qualifications: 

  • Bachelor of Science, Electrical Engineering, or equivalent technical training plus 10 years related experience working on various automation systems 
  • 7+ years’ experience working within GxP environment 

Preferred Qualifications: 

  • Experience using collaborative online document editing and cloud storage concepts 
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices 
  • The ability to work within an instrument calibration program and relevant experience calibrating instrumentation is highly desired 
    • Ability to work on-call rotation for the Everett manufacturing site 
    • Understanding of computer system validation 

 

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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PI195457006

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Posted: 2022-10-28 Expires: 2022-11-27

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Associate Director Automation

Seagen
Bothell, Washington 98021

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