Job Detail

Validation specialist

Inseriert am: 23.04.2021

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 R0032932Date posted 05.04.2021Location 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


Takeda Neuchâtel


Site de Production Biotech | Biotech Manufacturing Site


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’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced


Job Description:


As Validation Specialist you will be responsible for validation strategy definition, planning, execution and reporting of validation tasks within the Manufacturing Sciences department. The role responsibility covers developing strategy, writing both protocols and final reports, as well as ensuring execution of Process Validation 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 validation activities. He/she represents the validation on project teams and interfaces with peers in various other departments such as engineering and manufacturing to ensure Validation strategy and execution are conducted according to established quality standards as well as Regulatory requirements.

Essential Duties & Responsibilities :



  • Maintain and develop expertise Process Validation according to Takeda and Regulatory standards

  • Elaborate validation strategy and write validation plan according to Takeda standards procedures.

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

  • Participate in validation activities from 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 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

  • Participate in the “community of practices” within validation Takeda network.

    Required Skills:

  • We are looking for a strong energetic team player with good communication skills,

  • Ability to lead effectively and efficiently validation engineering topics

  • Ability to manage multiple priorities in a manufacturing plant setting

  • Ability to analyze, review and interpret 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 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 validation in a pharmaceutical/biotechnology industry.

  • Experience in Validation Strategy elaboration for complex and multiproduct manufacturing lines

  • cGMP  skills

  • Broad validation knowledge, industrial trends and validation related literature

  • Solid computer skills including Word, Excel, PowerPoint.

  • Very good French level (oral and written)

  • Good English level (oral and written)


Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0032932Apply NowEmail Me

Back to Job Navigation (Responsibilities)


Validation specialist

Apply NowJob ID R0032932Date posted 05.04.2021Location 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


Takeda Neuchâtel


Site de Production Biotech | Biotech Manufacturing Site


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’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced


Job Description:


As Validation Specialist you will be responsible for validation strategy definition, planning, execution and reporting of validation tasks within the Manufacturing Sciences department. The role responsibility covers developing strategy, writing both protocols and final reports, as well as ensuring execution of Process Validation 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 validation activities. He/she represents the validation on project teams and interfaces with peers in various other departments such as engineering and manufacturing to ensure Validation strategy and execution are conducted according to established quality standards as well as Regulatory requirements.

Essential Duties & Responsibilities :



  • Maintain and develop expertise Process Validation according to Takeda and Regulatory standards

  • Elaborate validation strategy and write validation plan according to Takeda standards procedures.

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

  • Participate in validation activities from 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 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

  • Participate in the “community of practices” within validation Takeda network.

    Required Skills:

  • We are looking for a strong energetic team player with good communication skills,

  • Ability to lead effectively and efficiently validation engineering topics

  • Ability to manage multiple priorities in a manufacturing plant setting

  • Ability to analyze, review and interpret 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 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 validation in a pharmaceutical/biotechnology industry.

  • Experience in Validation Strategy elaboration for complex and multiproduct manufacturing lines

  • cGMP  skills

  • Broad validation knowledge, industrial trends and validation related literature

  • Solid computer skills including Word, Excel, PowerPoint.

  • Very good French level (oral and written)

  • Good English level (oral and written)


Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



Job ID R0032932Apply NowEmail Me