MSAT Senior Engineer Packaging

Product Supply Operations Bothell, Washington


Description

Summary: 

The MSAT Sr Engineer is part of a team of highly skilled Scientists and Engineers responsible for technical and scientific support to manufacturing of Seattle Genetics products (clinical or commercial), whether manufactured internally or at contract manufacturing organizations (CMO’s). The incumbent collaborates with peers from Product Supply (primarily Packaging Operations) and Process Sciences/Process Development to ensure primary and secondary packaging design meets patient, regulatory and manufacturing robustness requirements. The Sr MSAT Engineer may lead or contribute to packaging technology transfers to or between contract manufacturers and will support packaging equipment selection and qualification and packaging process validation. The incumbent, in close collaboration with the Packaging Operations, will support GMP manufacturing including person-in-plant presence and trouble-shooting activities at CMO’s. The MSAT Sr Engineer provides technical and scientific leadership as subject matter expert (SME) in packaging (including all packaging materials) and related technologies.

 Principal Responsibilities

  • Support packaging of biologics, small and large molecule (drug substance and drug product) for clinical and commercial manufacturing internally or at CMO’s
  • The design, development, planning (in partnership with Packaging Operations) and implementation of product packaging for new products as well as evaluation and improvement of existing packaging designs
  • Design, testing and validation of the packaging materials and packaged product (stability studies, extractables and leachables, transport studies, patient handling studies etc)
  • Lead/manage strategic packaging projects and Technology Transfers (collaborating with Packaging Operations, Process Sciences, Manufacturing, Marketing and the Commercial organizations) from project initiation to closure including after action reviews
  • Collaborate with Packaging Operations and Process Sciences to ensure that the packaging designs are optimized for the product (stability, integrity etc) and manufacturability
  • Establish standards and guidelines for supplier evaluation. Evaluate and select packaging suppliers/vendors in collaboration with Packaging Operations. Develop, establish and implement appropriate packaging specifications in collaboration with Packaging Operations
  • Identify, assess and drive forward key innovation opportunities. Transition these new design/technologies into the Manufacturing environment/sites
  • Providing technical and scientific leadership as subject matter expert (SME) relating to packaging materials, design, manufacturing processes, packaging technologies, technology transfers, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control, process optimization and packaging regulations
  • Takes accountability and is the person-in-plant during key tech transfer, validation studies and commercial manufacturing
  • Provides guidance for root cause investigations of packaging related deviations in a timely, comprehensive and conclusive manner. Leads the data analysis of process data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements
  • Develops Standards, Guidelines and SOP’s in collaboration with Packaging Operations to enhance the quality and robustness of our Packaging Design, Implementation and Manufacturing Packing operations, knowledge transfer and technical support processes

 Qualifications:

  • Demonstrated knowledge and proficiency in packaging design, packaging materials and packaging operations (including understanding of the relationship between product, process, packaging equipment and packaging materials)
  • Knowledge and experience of both primary and secondary packaging
  • At least 8 years relevant experience in the Pharmaceutical/Cosmetics/Food industry packaging design, development and operations
  • Working knowledge of cGMP and the Pharmaceutical Regulatory framework
  • The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
  • Experience working with Contract Manufacturing Organizations is desirable
  • Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seattle Genetics
  • The candidate must demonstrate high levels of integrity. Key competencies are management of complexity, driving for results, problem-solving and collaborating cross-functionally
  • Strong communication skills and computer literacy are essential
  • Experience with innovation and operational excellence is desirable

 Education:

  • Minimum of a Bachelor’s Degree in Engineering or Science which includes Packaging within the course and a minimum of 8 years relevant industrial experience

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics 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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