Process Engineering Manager jobs in Seattle, WA

Process Engineering Manager manages a team responsible for the design and implementation of manufacturing processes, equipment, or plants. Responsible for operational excellence via efficient plant design. Being a Process Engineering Manager ensures continuous improvement in process, cost, quality and production. Manages all engineering projects and resolves engineering problems. Additionally, Process Engineering Manager requires a bachelor's degree of engineering. Typically reports to a manager or head of a unit/department. The Process Engineering Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. To be a Process Engineering Manager typically requires 3+ years of managerial experience. (Copyright 2024 Salary.com)

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Associate Director, Process Engineering
  • Seagen
  • Bothell, WA FULL_TIME
  • 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 Associate Director is part of the technical leadership team tasked to enable and support production of Seagen’s clinical and commercial products at North Creek. This role is responsible for establishing and leading the process engineering function which provides support to manufacturing operations, new capabilities and technology implementation, process data collection, deviation investigations and change management, continuous improvement initiatives, and capital projects. The incumbent is a subject matter expert in biopharmaceutical operations and processing equipment. Incumbent will be versed in equipment design, installation and qualification, asset lifecycle management, and has thorough understanding of process equipment integration with different automation and control platforms. The ideal candidate has a proven track record leading process engineering projects, displaying creativity, technical expertise, and cross-functional collaboration.

    Principal Responsibilities

    • Build, lead, and manage a manufacturing process engineering team, providing technical support specific to antibody intermediate and DS processes and equipment
    • Partner in technical/process transfers from internal and external sources
    • Troubleshoot and resolve process, equipment issues in the field
    • Develop and issue cGMP compliant design documents and protocols
    • Provide technical expertise to lead and close investigations, non-conformances, and corrective actions
    • Provide technical and team leadership for process engineering tasks and initiatives across Seagen manufacturing sites
    • Work in collaboration with MSAT, Technical Development, Manufacturing, and Facilities teams to support the implementation of new manufacturing capabilities, technologies, process automation, and control systems
    • Assist in the generation of relevant regulatory submissions
    • Identify process and technology gaps and issues; develop solutions and implementation plans
    • Participate and support internal and regulatory authority facility audits and site inspections
    • Provide strong leadership, guide, and mentor staff to ensure productive and collaborative organizational performance and individual career growth
    • Contribute to the design of new equipment and systems. Support specification development, supplier screening and selection, installation and qualification, asset ownership and lifecycle management
    • Support minor and major capital projects, including equipment and facility updates, expansions, new facility planning and design, systems qualification, and start-up. Work with IT, Facilities, and other internal groups to ensure process and equipment requirements fit SeaGen standards and building and utilities capabilities
    • In collaboration with Data Sciences, MSAT, and Manufacturing, support and drive improvements related to manufacturing process data collection, monitoring capabilities, and data trending
    • In collaboration with MSAT, support and lead initiatives and changes aimed to improve yield, cycle times, process robustness, decrease cost and reduce risk
    • Ensure that Quality systems related tasks are closely managed, including training, investigations, change controls, and corrective actions
    • Hire direct-line reporting staff. Working closely with leadership, develop strategic plans and priorities for the Process Engineering group. Ensure all high priority tasks are properly resourced
    • Ensure the team actively supports the implementation of best practices, procedures, and technologies. Drive a philosophy of operational excellence, continuous improvement, and risk reduction

    Required Qualifications

    • 10-15 years of experience in a life science regulated industry (pharmaceutical or biotech)
    • BS/MS degree in Biochemical Engineering, Biotechnology, or Life Science; relevant experience will be considered
    • In-depth knowledge of equipment, operations, and engineering principles related to biotherapeutic antibody intermediate and drug substance manufacturing, including disposable technologies
    • Exceptional leadership skills to thoughtfully guide teams and individuals
    • Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical leadership to individuals within the team
    • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and teamwork
    • Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making
    • Capacity to develop solutions for technical issues of difficult scope
    • Demonstrated close partnership with cross-functional groups (Technical Development/Mfg/MSAT/Quality/Facilities) to ensure uninterrupted and compliant product supply.
    • In-depth knowledge of US and applicable global regulations including ICH Q10, 21CFR210&211, Eudralex Volume 4, EU Annex 1, and GAMP 5
    • Proven leadership ability to carry out difficult tasks in a logical and rational manner
    • Demonstrated ability to communicate effectively to internal and external teams at all levels

    Preferred Qualifications

    • Experience with manufacturing processes that utilize single-use technologies and systems
    • Working knowledge of ADC mAb conjugation processes
    • Experience in helping to build and maintain a Mfg. Operations infrastructure in a fast-paced and growing company
    • Demonstrated success effectively leading a process engineering function supporting clinical and commercial cGMP biologics manufacturing
    • Expert knowledge in cGMP bioprocessing equipment and utility systems.
    • In-depth experience with automation processes, control systems programming for manufacturing equipment, SCADA and DCS systems and related components (PLCs, HMIs, servers, and data historians)
    • Well-versed in data integrity requirements and application in bioprocessing and data management including electronic batch records
    • Direct experience with high-potency manufacturing and equipment; close understanding of containment requirements and controls
    • Direct exposure / experience with health authority inspections


    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 $164,000 - $212,000 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.

    #LI-KC1

  • 9 Days Ago

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Engineering Supervisor (Mechanical/Process)
  • The Lisbon Group, LLC
  • Mercer Island, WA FULL_TIME
  • Help make the future possible today! We are currently growing our energy transition operations capability. We are looking for a passionate and hardworking Mechanical or Process Engineering Supervisor ...
  • 2 Months Ago

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DELMIA Developer (DELMIA Process Engineering)
  • Sapear Inc
  • Seattle, WA FULL_TIME
  • DELMIA Developer (DELMIA Process Engineering) Seattle, WA Full Time Job description: Delmia Process Engineering, how to create work instructions that mechanics use to take the parts and create Product...
  • 1 Day Ago

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INTERNSHIP - Mechanical Engineering Process Consultant
  • Dassault Systemes
  • Bellevue, WA FULL_TIME
  • Responsibilities As a Mechanical Engineering Process Consultant Intern, you will have an opportunity to learn about modeling and simulating in 3D using CATIA 3DEXPERIENCE. You will gain hands on exper...
  • 1 Month Ago

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Process Manager
  • Microsoft Legal Department
  • Redmond, WA OTHER
  • Job Duties Microsoft Corporation has the following job opportunity: Job Description: Develop a scalable and effective technical strategy to support the rhythm of the business and organizational goals....
  • 6 Days Ago

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Business Development Manager
  • PENN ENGINEERING
  • Seattle, WA FULL_TIME
  • At PennEngineering, we innovate and collaborate to make the world a better place. You can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We’re ...
  • 22 Days Ago

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0 Process Engineering Manager jobs found in Seattle, WA area

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Informatica Engineer-ePIM / Product 360 - Charlotte, NC Remote
  • Themesoft Inc.
  • Seattle, WA
  • Job Title: Informatica ePIM / Product 360 / Oracle Data engineer Client Location: Charlotte, NC (open for remote) Inform...
  • 3/19/2024 12:00:00 AM

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Director of BESS Engineering | DC (open to remote) | Utility & DG BESS
  • Viridan Group
  • Seattle, WA
  • Director of BESS Engineering | DC (open to remote) | Utility & DG BESS Are you a Snr Engineer in the energy storage spac...
  • 3/19/2024 12:00:00 AM

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Engineering Manager
  • Accretive Technology Group
  • Seattle, WA
  • This role is fully remote in the following states:?Arizona, California, Colorado, Florida, Idaho, Michigan, Missouri, Ne...
  • 3/18/2024 12:00:00 AM

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Transportation Project Engineer
  • NV5
  • Seattle, WA
  • Overview: NV5 is a provider of engineering and consulting services to public and private sector clients, delivering solu...
  • 3/17/2024 12:00:00 AM

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Second Assistant Engineer/QMED
  • American Seafoods
  • Seattle, WA
  • Duties and Responsibilities Assist the Chief Engineer and the 1st Engineer as necessary in the operating, maintaining an...
  • 3/15/2024 12:00:00 AM

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Test Engineer
  • Pikemann LLC
  • Seattle, WA
  • 100% remote!!! Pikemann is hiring a Test Manager who can apply their analytical skills to ensure the quality and reliabi...
  • 3/15/2024 12:00:00 AM

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Senior Service Technician - Security Solutions
  • Allied Universal® Technology Services
  • Seattle, WA
  • Overview When you join the Allied Universal® Technology Services, you are joining one of the fastest growing security sy...
  • 2/14/2024 12:00:00 AM

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Senior Service Technician - Security Solutions
  • Allied Universal® Technology Services
  • Kirkland, WA
  • Overview When you join the Allied Universal® Technology Services, you are joining one of the fastest growing security sy...
  • 2/14/2024 12:00:00 AM

Seattle (/siˈætəl/ (listen) see-AT-əl) is a seaport city on the West Coast of the United States. It is the seat of King County, Washington. With an estimated 730,000 residents as of 2018[update], Seattle is the largest city in both the state of Washington and the Pacific Northwest region of North America. According to U.S. Census data released in 2018, the Seattle metropolitan area’s population stands at 3.87 million, and ranks as the 15th largest in the United States. In July 2013, it was the fastest-growing major city in the United States and remained in the Top 5 in May 2015 with an annual...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Process Engineering Manager jobs
$155,177 to $191,677
Seattle, Washington area prices
were up 2.8% from a year ago

Process Engineering Manager in Rochester, MN
Ensure that the process standards, procedures and specifications are in place for the assets.
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The Aircraft and System Assembly team takes care of all jet assembly processes, integrating the many individual components into the final Lilium Jet product.
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In a general sense, process engineering is a vast field that encompasses most disciplines of engineering, so the type of engineering degree you’ll need will be one that’s relevant to your employer’s area of operations.
January 12, 2020