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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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CSV Technician

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Job ID R0011154 Date posted 08/02/2019 Location Madrid, Spain

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Job Description

Major accountabilities:

  • Execution of Validation/Qualification activities, including but not limited to (VMP/RA/DQ/COMM/IQ/OQ/PQ/TM & Functional and Design Specifications).
  • Preparation and review of GxP impacted Computerized System Validation protocols and reports, as well as FS/SDS/HDS/SMDS documents.
  • Preparation and review of new/revised standard operating procedures (SOP’s), forms, flow diagrams, specifications, etc.
  • Maintaining the validated status of existing systems according to the Validation Master Plan of the site.
  • Management and coordination of internal and external personnel for the execution of validation tasks.
  • Negotiation of needed computerized system validation services.
  • Provided compliance and regulatory guidance for existing and new computerized systems, design review, installation and implementation.
  • Carry out the internal control responsibilities set forth for the procedures of your job
  • Whatever other task in compliance with the CBA (art.22 & art.26)

Skills, experiences and qualifications required for the job:

  • Science or Engineering Degree, Electronic or Informatic Degree. Master is a plus.
  • Experience (years/area):
  • +3 years of experience in a similar position.
    • Experience implementing and commissioning/validation of Control/Automation peripheries, SCADA (EMS/BMS + Historian), CMMS, ERP, LIMS, according to GAMP 5, 21CFR11, GMP Annex 11 and/or specific regulations.
  • Experience in equipment/utilities Qualification and calibration will be a plus.
  • Fluent Spanish and English (min. B2), knowledge of other languages will be an asset.
  • Open to travel punctually (<5%).

Skills:

  • Good analytical skills, accuracy, reliability, attention to detail.
  • Proactive and dynamic. Able to work as part of a team but also having the confidence to work alone.

Analytical and with the ability to plan tasks and/or projects.

Locations

Madrid, Spain

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0011154

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