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What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix

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Engage Others Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients; provides appropriate background so that messages are meaningful with audiences.

Collaboration Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals.

Drive for Results Holds self and others accountable for delivering on commitments that align with our short- and long-term goals, never forgetting the end result is to help patients through innovation in medicine.

Strategic Approach Makes sound decisions that are consistent with our mission, values and organizational objectives.

Lead Change Proactively evaluates, promotes, and initiates change that creates value for patients, the organization, and our shareholders.

Self Awareness Seeks feedback from others, modifies self-perceptions and actions based on this feedback, and actively develops skills and behaviors to enhance contribution.

Develop Capabilities Seeks opportunities to develop oneself and others so that we can continue to achieve sustained growth.

Rewards

  • Teamwork

    Takeda builds strong, borderless and empowered teams through fairness and promoting shared goals. By working together, we optimize energy and can lead the change for a better world.

  • Innovation

    Takeda implements bold initiatives on a daily basis by striving for continuous improvement and encouraging enthusiasm and creativity. This value speaks to attracting the best minds in the industry that are committed to delivering novel therapies to patients worldwide.

  • Diversity

    Takeda respects and includes a broad range of people and ideas in its daily operations. Our organization encourages each individual to act with empathy and to apply their unique skills to realize the company’s true potential.

  • Passion

    Takeda's drive comes from perseverance, urgency and a strong desire to contribute to patients. We put this passion to work in everything we do and demonstrate courage to fight for ideas and objectives to raise the quality of our solutions, create stronger ties with our stakeholders, and deliver results.

  • Commitment

    Takeda works to meet its responsibilities to stakeholders on a daily basis. We provide adequate support and challenge to ensure we deliver high-quality solutions that help more people around the world.

  • Transparency

    Takeda appropriately shares information and promotes honest, sincere dialogue with stakeholders to build trust. This trust enables us to strengthen our relationships with employees and external communities.

Videos

  • Medicine for the World

  • Quality at Takeda

  • Entyvio Video

News and Events

  • Moving Mountains

    Takeda Pharmaceuticals was one of 266 employers recognized for excellence in workplace safety at the Governor's Safety Awards luncheon on May 18 at the Minneapolis Convention Center. This award from the Minnesota Safety Council joins a long list of workplace awards Takeda has earned based on its employee policies and programs.


    Click here for more information

  • One Vision: We aspire to cure cancer.

    Takeda Pharmaceuticals is continuously empowering our people to shine, creating better health and brighter futures for people worldwide. Working with us, you will make a positive impact on people’s lives every day—including your own.

    Our inclusive, focused and diverse Takeda community works together and is inspired and supported to perform to the very best of their ability.


    Click here for our corporate profile

  • Our communities

    Takeda Pharmaceuticals is on the cutting edge of innovation, for more information on our latest breakthroughs and discoveries visit our newsroom today!


    Click here to access our newsroom

Overview

Takeda is a global, innovation-driven pharmaceutical leader with 30,000 professionals working together across more than 70 countries. We have maintained an unwavering dedication to put patients first for more than 235 years while we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

We focus our research and development on the core therapeutic areas of oncology, gastroenterology, neuroscience, and on providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Takeda’s Brooklyn Park manufacturing facility provides long-term strategic benefits by enhancing Takeda’s capacity to manufacture additional commercial products and investigational drugs under clinical development. This plant allows Takeda to establish and develop direct commercial bio-manufacturing expertise, and is poised to be a world-class biologics drug substance production facility. When fully constructed, it will be a 215,000 square-foot facility manufacturing multiple antibody products, including Entyvio.

Responsibilities

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Principal Validation Engineer in our Brooklyn Park, Minnesota office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Principal Validation Engineer working on the Engineering team, you will be empowered to define validation strategies and provide leadership for validation projects, and a typical day will include:

  • The role supports the validation of plant automation and process control systems, along with QC laboratory and Desktop based business and analytical systems.
  • The role will provide leadership in scheduling, planning and execution of validation projects for site based computer systems.
  • The role will develop, complete, log and archive computer systems validation documentation.

Accountabilities include:

  • Defining validation strategies and oversight through the implementation of validations plans for site based computer systems.
  • Sound industry knowledge, project proficiency, and autonomy expected.  Considered a validation Subject Matter Expert (SME) in the areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
  • Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP® 5 requirements.
  • Lead risk assessments to identify critical SDLC activities and deliverables during the implementation and validation of various computer systems.
  • Plan computer validation projects and track execution of validation activities versus project timeline.  Manage and plan the work of the internal and contract resources.
  • Perform change control assessments and write/review validation plans, qualification protocols and summary reports.  Manage the execution of qualification protocols and review test results.
  • Mentor junior staff in their job performance and project related activities.
  • Supporting development of best demonstrated validation practices within the validation department, based on current industry practices and regulatory guidelines.

Education, competencies, and skills desired include:

  • Minimum of a BS in Sciences/Engineering (other degrees accepted provided the individual has relevant experience
  • Minimum of 5-8 years’ relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry with 2-3 years experience in leading resources and projects
  • Working knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, EU's Annex 11 guidelines and other international regulatory requirements.
  • Have previous validation experience in Rockwell Automation, FTView SE, ControlLogix, FTBatch, SQL Databases and OSI Pi as well as lab equipment and software such as QC LIMS and Empower, building automation, and IT infrastructure.
  • Sound industry knowledge, project proficiency, and autonomy expected.  May be considered a Subject Matter Expert (SME) in related disciplines.
  • Lead and manage various validation activities and author/review related documents including validation plans, risk assessments, 21 CFR compliance assessments, qualification protocols, and summary reports.
  • Lead qualification protocol execution, and manage protocol deviations investigation and corrective action activities
  • Participate in user/system requirements gathering, design qualification, and CAPA investigations.
  • Collaborate closely with supplier quality and system owners in defining the role of software suppliers. Assist in evaluation and oversight of supplier activities and documentation related to system qualification.
  • Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
  • Proficient in Microsoft Word and Excel, Project and other desktop computing software.
  • Able to establish and manage multiple cross-functional teams simultaneously.
  • Project management experience preferred

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


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Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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