Validation Engineer

Takeda

Neuchâtel
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  • Publication date:

    25 September 2022
  • Workload:

    100%
  • Contract:

    Unlimited employment
  • Language:

    English, French

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world

Validation Engineer

Job description:

About the role :

As Validation Engineer 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 C&Q & CSV validation activities for the site.

As Validation Engineer 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.

How you will contribute :
The Validation Specialist performs, troubleshoots and supports the manufacturing qualification activities. He/she performs a variety of activities to support CSV, 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 framework 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 profile:

What you bring to Takeda :

  • 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
Education & Experiences:
  • Engineering degree or equivalent
  • 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)

What we offer:

What Takeda can offer you:

  • Attractive salaries
  • Full accident cover
  • Participation in health insurance premiums
  • Advantageous retirement plans
  • Subsidized meal
  • Financial participation in the sports practices of its employees
  • Transportation: support in local public transport, free parking, carpooling program
  • Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
  • Takeda Neuchâtel is an employer committed to its employees and future generations
More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law.

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