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CSV/DI & Laboratory Equipment Qualification 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.

  • 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/DI & Laboratory Equipment Qualification Specialist

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Job ID SR0038573 Date posted 07/11/2019 Location Neuchâtel, Switzerland

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Control Equipment Qualification Specialist.

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Control teams within a world-class Biotech GMP manufacturing environment.

Job summary

The job holder is accountable for the laboratory instruments qualification, including Computerized System Validation (CSV) in the QC laboratories of Neuchâtel - Switzerland. In addition, the job holder also supports the deployment of Data Integrity (DI) in the department.

Essential duties and responsibilities

  • Ensure computerized system validation strategy within QC department as well as providing laboratory equipment validation expertise
  • Comply with GMP and Data Integrity requirements through applicable guidelines and procedures
  • Define and follow-up the CS Validation Strategy (Validation Plan)
  • Review / Approve User System Requirement (URS), Functional Specification and Design Specifications
  • Lead Risk Assessments
  • Write Design Qualifications
  • Writing qualification protocols (IOPQ) and reports for quality control instruments, including computerized systems
  • Ensure the readiness of instruments for validation activities (i.e. with feasibility protocols)
  • Support analytical technical transfer of assays requiring Analytical Instrument Qualification activities (AIQ)
  • Oversee qualification activities executed by QC analysts, provide training and support
  • Coordinate instruments periodic review
  • Support and prepare inspections, audit responses and regulatory submissions

Education & Experience

  • Bachelor or engineering degree in a technical field
  • Min 3 years of experience in Analytical Instrument Qualification (AIQ) and Computerized System Validation (CSV) activities
  • Experience in GMP laboratory activities and good knowledge of Data Integrity requirements
  • Fluent in French and English (C1 written and spoken)

Qualifications

  • Excellent computer skills (Word, Excel, Power Point, MS Project)
  • Able to set his/her own priorities and tight timelines
  • Good interpersonal, organizational, and communication skills
  • Ability to synthesize information and defend conclusions publically

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 SR0038573

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