Job Detail

Validation Specialist

Inseriert am: 23.02.2021

Validation Specialist


Neuchâtel, Switzerland

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  • Overview

  • Success

  • Life at Takeda

  • Opportunity

  • Responsibilities

  • Map


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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Life at Takeda



  • A Global Top Employer

    Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2021.


  • At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.

    Global Manufacturing

    Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.


  • About Takeda

    At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.



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Opportunity



  • Innovation

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


  • Inclusive

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


  • Empowerment

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


  • Collaboration

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


  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.


  • Work-Life

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



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Validation Specialist

Apply NowJob ID R0030063Date posted 02.12.2021Location Neuchâtel, Switzerland

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.


Job Description


At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.


Job Posting Title: Validation Specialist _ CSV/IT


Job Description:


As Validation Specialist you will be responsible for planning, execution and reporting of validation tasks within the Engineering Services department. The role responsibility covers definition of validation strategy, creating, executing and enhancing CSV/IT 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, Automation, process Engineering 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 qualification activities of manufacturing equipment. He/she performs a variety of activities to support CSV/IT and C&Q. 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:



  • Support the preparation of projects documents, such as: URS, RIAS, FS process, FD, P&IDs, traceability Matrix,

  • Provide Validation Expertise to support evaluation of:, protocol deviations, CAPA, Change control, solving problems/root cause in case of routine and project issues.

  • Define validation strategy according to Takeda and regulatory standards.

  • Maintain and develop expertise in CSV/IT and CQV activities according to Takeda and Regulatory standards

  • Write, review and approve Validation documents (RIAS, VPP, validation protocols/reports, SOPs…etc.) according to Takeda and Regulatory standards

  • Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.

  • 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 member 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

  • Knowledges in cleaning and sterilization validation would be appreciated

    Requirements:

  • Engineering degree or equivalent

  • At least 5 years’ experience in the pharmaceutical/biotechnology industry with CSV/IT background (relevant IT System such as MES,ERP..etc.)

  • 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)


Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0030063Apply NowEmail Me

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Validation Specialist

Apply NowJob ID R0030063Date posted 02.12.2021Location Neuchâtel, Switzerland

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.


Job Description


At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com.


Job Posting Title: Validation Specialist _ CSV/IT


Job Description:


As Validation Specialist you will be responsible for planning, execution and reporting of validation tasks within the Engineering Services department. The role responsibility covers definition of validation strategy, creating, executing and enhancing CSV/IT 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, Automation, process Engineering 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 qualification activities of manufacturing equipment. He/she performs a variety of activities to support CSV/IT and C&Q. 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:



  • Support the preparation of projects documents, such as: URS, RIAS, FS process, FD, P&IDs, traceability Matrix,

  • Provide Validation Expertise to support evaluation of:, protocol deviations, CAPA, Change control, solving problems/root cause in case of routine and project issues.

  • Define validation strategy according to Takeda and regulatory standards.

  • Maintain and develop expertise in CSV/IT and CQV activities according to Takeda and Regulatory standards

  • Write, review and approve Validation documents (RIAS, VPP, validation protocols/reports, SOPs…etc.) according to Takeda and Regulatory standards

  • Coordinate and follow-up validation protocols execution, ensuring that all validation activities and documents are completed and documented in a timely manner.

  • 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 member 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

  • Knowledges in cleaning and sterilization validation would be appreciated

    Requirements:

  • Engineering degree or equivalent

  • At least 5 years’ experience in the pharmaceutical/biotechnology industry with CSV/IT background (relevant IT System such as MES,ERP..etc.)

  • 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)


Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0030063Apply NowEmail Me