Seagen
Principal Automation Engineer
Corporate Functions - Bothell, Washington
Description
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 Automation Engineer serves as a highly technical resource for equipment, control systems, and processes across Seagen’s’ sites. This position supports all aspects of the pharmaceutical/biotech environments including manufacturing, lab spaces, and general building operations. The incumbent will resolve technical and process challenges in a regulated GxP environment requiring the candidate to possess strong communication skills allowing the collaborate across multiple departments. The individual must be fully proficient in everything that involves the Automation and controls realm. This technology professional is able to comprehend and adhere to all applicable site SOPs and policies within regulated manufacturing and lab environments. This individual will also utilize validation experience and expertise to draft, review, and execute validation documentation and activities including computerized system validation (CSV).
Principal Responsibilities:
- Perform system design, installation, programming, validation and on-going administration responsibilities for Process Automation System(s) and Building Automation System(s) in GxP and Non-GxP Spaces
- Perform maintenance and support work for manufacturing operations, lab environments/equipment, and office spaces
- Engineer, maintain, and troubleshoot information systems, communications, and infrastructure related to SCADA, DCS, and instrument systems
- Assess impact and performs updates to automation control systems and their supporting software and operating systems in order to maintain functionality and security while ensuring qualified/validated state is maintained
- Contributes with the development of the Automation Strategy for the site
- Administer remote alarm notifications from various systems, including the setup and modification of equipment alarms, person contacts, group escalations, and devices
- Oversee and assist with the installation and troubleshooting of flow (Gas and Liquid), temperature, pressure, weight, and analytical (pH, Dissolved Oxygen, and Conductivity) instrumentation
- Work directly with Quality Assurance and other compliance groups to create, review, and execute validation protocols
- Ability to work in an Enterprise Asset Management (EAM) and/or Computerized Maintenance Management System (CMMS) to track assets and execute work. Ability to perform administration and maintenance activities on the system are desired
- Create, review, redline, and/or update system and process drawings for wiring, process, and system changes
- Suggest the adoption of new software and follow the guidelines like GAMP5 to execute Automation work to make processes more efficient and compliant
- Perform PID loop tuning for various process control variables including temperature, flow, pH, and Dissolved Oxygen
- Use of business intelligence tools including reporting applications and report engines (Crystal Reports, BiRT, Microsoft SSRS) to design, modify, and run reports from various systems and databases to provide end users with data for both business and regulatory needs
- Use internal quality systems to generate, assess, and perform change control, deviations, investigations, and CAPA records
- Work on project teams during design, engineering, and implementation phases to coordinate automation systems and assure alignment to corporate and site standards
- Act as subject matter expert for systems of responsibility
- Participate in GxP training program to maintain compliance with all site standards and procedures
- Participate as a subject matter expert in regulatory audits and other audits
Qualifications:
- 10+ years’ experience working in a regulated GxP environment
- Ability to review and redline electrical drawings, instrument loop diagrams and P&ID drawings in support of engineering and maintenance activities
- Experience using an Enterprise Asset Management system (Maximo) to track, record, and log the status and history of assets and work performance
- Ability to work with instrumentation/calibration teams in support of automation systems troubleshooting and instrument selection, instrument diagnostics, and coordination of calibration process for in place instruments
- Ability to analyze and repair highly complex interconnected automated process control systems with multiple communications protocols, end devices, and instrumentation
- Strong understanding of ladder logic, function block, and structured text-based programming concepts in relation to industrial programmable controllers
- Strong familiarity with SCADA and DCS systems and concepts such as Allen Bradley Factory Talk, Siemens WinCC, Wonderware, iFix, Emerson DeltaV or similar systems
- Experience working with process historians (Wonderware Historian, iHistorian, Pi, or similar) including administration and processing of live and historical data for trending, alarms, and batch reports
- Strong computer and controls networking background including Ethernet, RS-485/422, and RS-232 along with control systems communications protocols (BACNET, MODBUS, EtherIP, ProfiBUS, CANBUS)
- Experience using collaborative online editing tools for documents and cloud storage concepts (SharePoint, BlueBeam, OneDrive)
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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 11/26/2021
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