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Validation Engineer II - (GMF109)

Lessines, Belgium

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

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

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Validation Engineer II - (GMF109)

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Job ID SR0037295 Date posted 06/17/2019 Location Lessines, Belgium

For Set-up and Filling systems in aseptic area, the main activities are:

  • Prepare and implement the validation documentation required to assure the proper development of a project. Act as a validation representative for projects, with support of his/her Validation Supervisor /Validation Lead
  • Define and implement all validation activities related to the project.
  • Develop the Validation Plans: define validation methodology and approach. submit to the Validation Supervisor /Validation  Lead for review.
  • Provide validation expertise for the development of the project.
  • Lead  the risk assessment related to the project.
  • Support & Review the URS, FS and DS definition.
  • Write and implement FAT, IQ, OQ & PQ protocols.
  • Assure requirements traceability throughout the whole project validation file (from URS to PQ).
  • Organize and coordinate FAT, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) in such a way that all of them concur with the timeframes committed with the project leader.
  • Analyze, interpret, document and report the testing results.
  • Ensure the follow-up and tracking of the validation activities. Update the validation documentation system.
  • Assure feedback of status and issues to the Validation Supervisor.
  • Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
  • Manage deviations and cin internal/external audithanges in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.
  • Take part in internal/external audit
  • Provide the required information to support the preparation of facility & process related files for the various regulatory agencies.
  • Support the coordination of junior validation engineers and contractors.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.



Job ID SR0037295

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