Job Detail

Validation Expert

Inseriert am: 08.06.2020

Validation Expert


Neuchâtel, Switzerland

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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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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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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 2020.


  • 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.


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


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  • Work-Life

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Validation Expert

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Job ID SR0049768
Date posted 06.08.2020
Location Neuchâtel, Switzerland

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 and C&Q


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 and C&Q 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 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, VPP/PDV.

  • Provide Validation Expert support and evaluation to: Validation strategy definition, aproach, protocol deviations, CAPA, Change control, solving problems/root cause of routine and project issues.

  • Maintain and develop expertise in CSV and C&Q 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 8 years’ experience in the pharmaceutical/biotechnology industry, preferably with CSV background

  • 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 SR0049768

Apply NowEmail Me

Back to Job Navigation (Responsibilities)


Validation Expert

Apply Now
Job ID SR0049768
Date posted 06.08.2020
Location Neuchâtel, Switzerland

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 and C&Q


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 and C&Q 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 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, VPP/PDV.

  • Provide Validation Expert support and evaluation to: Validation strategy definition, aproach, protocol deviations, CAPA, Change control, solving problems/root cause of routine and project issues.

  • Maintain and develop expertise in CSV and C&Q 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 8 years’ experience in the pharmaceutical/biotechnology industry, preferably with CSV background

  • 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 SR0049768

Apply NowEmail Me