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Validation Specialist

Neuchâtel, Switzerland

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.

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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 Specialist

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Job ID SR0038290 Date posted 06/28/2019 Location Neuchâtel, Switzerland

As Validation Specialist you will be responsible for planning, execution and reporting of validation tasks within the Engineering Validation department. The role responsibility covers creating, executing and enhancing facility, equipment, utility, cleaning, and sterilization validation activities for the site.

As Validation Specialist you will have an active involvement in continues improvement, development and implementation of new initiatives. You will assure issue resolution arising from validation activities in cooperation with Quality, Technical Operations and Manufacturing (e.g. deviation handling, CAPA and change requests).

The role is expected to have a solid understanding of industry standards and validation compliance requirements and is required to supply support/technical knowledge for the development/refinement and implementation of validation standards.

Your mission:

The Validation Specialist performs, troubleshoots and supports the manufacturing qualification activities. He/she performs a variety of activities to support CIP/SIP, Equipment and Process validation. He/she represents the validation on project teams and interfaces with peers in various other departments such as engineering and manufacturing to ensure that design, implementation and qualification processes are conducted according to established quality standards.

Essential Duties & Responsibilities :

  • Maintain and develop expertise in CIP/SIP, Equipment, MQ and Process Validation according to Takeda and Regulatory standards
  • Write, review and approve Validation documents (validation protocols/reports, SOPs, RIAS, MVP...etc.) according to Takeda and Regulatory standards
  • Participate in validation activities from strategy, planning, execution to validation reports
  • Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.
  • Provide Validation expertise support related to strategy definition, problems solving, root cause analysis, CAPAs investigation and implementation steps
  • Participate in internal or external audits, as required. Follow-up on audit observations topics and ensure closure on time

    Required Skills:
  • We are looking for a strong energetic team player with good communication skills,
  • Demonstrated interpersonal and expertise skills with ability to interface well with other departments, and lead effectively and efficiently validation engineering topics
  • Ability to manage multiple priorities in a manufacturing plant setting
  • Ability to analyze, review and interpret engineering validation data
  • Must have uncompromising dedication to quality and an excellent understanding of cGMPs and other regulatory guidelines
  • Interpersonal skills that enables you to work with people at all levels
  • Ability to plan, multitask, and manage time effectively
  • Must display personal accountability for results and integrity
  • Must display eagerness to learn, to innovate, drive for solutions and continuously improvement

    Requirements:
  • Engineering degree or equivalent, preferably with biochemical or chemical background
  • At least 5 years’ experience in the pharmaceutical/biotechnology industry
  • cGMP and validation skills
  • Broad validation knowledge, industrial trends and validation related literature
  • Solid computer skills including Word, Excel, PowerPoint.
  • Very good English level (oral and written)
  • Very good French level (oral and written)

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 SR0038290

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