Seagen

MES Associate - Launchpad

Technical Operations & Process Sciences - Bothell, United States

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:

Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs). Seagen is seeking a Manufacturing Execution Systems (MES) Associate to join our new clinical and commercial biologics manufacturing facility. The focus of this position will be to actively participate and contribute to the MES platform design, configuration, testing and operational readiness. This position requires constant collaboration with other cross functional areas like Quality, IT, Engineering Automation, and external vendors.

The desired candidate must have a solid understanding of MES systems (design and configuration capabilities), coupled with a strong understanding of operations and system processes in a highly regulated environment. This person should have a strong ability to comprehend and adhere to all applicable site SOPs and policies within a highly regulated Life Science manufacturing environment. This role will be located in our new state-of-the-art facility in Everett, WA.

Principal Responsibilities:

• Perform MES system configuration tasks, peer reviews and lead design reviews with internal customers
• Participate in cross-functional teams to assess and communicate planning, development, and testing solutions for recipe creation and modification
• Work with process subject matter experts (SMEs) in the various areas to define business requirements and processes
• Collect and consolidate all information coming from Automation, LIMS and ERP systems to enable an electronic batch record (EBR) and support the product release
• Conceptualize, demonstrate, and execute solutions to address requirements and overcome platform and project constraints
• Demonstrate end to end understanding of process flow, able to deduce the requirements and develop a recipe with complete unit level processing
• Design, develop and build batch recipes per Standard Operating Procedures and Launch Pad project timelines
• Work closely with customer to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies
• Support senior engineers in the troubleshooting and resolution of issues/application software bugs from project teams and escalation to the MES vendor
• Deliver updates to system lifecycle documents such as User Requirements Specifications, Configuration Specifications, Function Specification, Design Specifications, and Test Cases
• Support the design and implementation of interfaces to systems such as PAS, LIMS, ERP, EDMS and standalone equipment

Expected Qualifications:

• Bachelor’s or Master's degree in Computer Science or engineering
• 0 to 2 years of experience working in a regulated, GMP manufacturing environment within the Life Sciences industry
• Ability to quickly learn MES software functionality, pharmaceutical production processes and related configuration processes
• Self-motivated, energetic and enthusiastic personality
• Strong communication skills, confidence in dealing with users and larger groups
• Collaborate in teams and adjust based on situations
• Strong team player, ability to take on different roles within a team

Preferred Qualifications:

• Internship in Pharma or Biotech industry or 1+ years of experience in Electronic Batch Record authorship
• Understanding of software project life cycle
• Familiarity with Data Integrity principles including, but not limited to 21 CFR Part 11
• Experience successfully interacting and working with customers at multiple levels of responsibility in a manufacturing or production environment
• Experience with Databases such as Oracle and MSSQL Server
• Ability to complete tasks independently with minimal oversight

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 $80,000 to $103,000 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.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 03/17/2023