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Validation Engineer (f/m/d)

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Takeda

24d ago

  • Job
    Full-time
    Mid & Senior Level
  • Engineering
    Healthcare

AI generated summary

  • You need a degree in natural sciences, validation experience in aseptic production, knowledge of cleaning/sterilization, vaccine production experience, and fluent German and English.
  • You will plan, document, execute, and report process validations, manage risk analyses, oversee cleaning and sterilization validations, track validation lifecycles, and support inspections.

Requirements

  • Completed studies in the natural sciences (biology, chemistry, pharmacy or comparable)
  • Experience in the validation of processes in an aseptic production environment
  • Experience with cleaning and sterilization procedures
  • Initial experience in vaccine production
  • Business fluent in written and spoken German and English

Responsibilities

  • Independent, timely planning, documentation, execution, evaluation and reporting of process validations as part of the dengue vaccine filling capacity expansion
  • Creation, processing and maintenance of risk analyses
  • Subject Matter Expert for the validation of cleaning and sterilization procedures for the entire site
  • Tracking the validation lifecycle for the area of responsibility
  • Evaluation of changes and deviations with regard to the validation impact, including definition of necessary measures
  • Support of authority, customer and self-inspections with regard to the area of responsibility

FAQs

What is the job title for this position?

The job title is Validation Engineer (f/m/d).

What are the main responsibilities of the Validation Engineer?

The main responsibilities include planning, documentation, execution, evaluation, and reporting of process validations as part of the dengue vaccine filling capacity expansion, creating and maintaining risk analyses, being a Subject Matter Expert for validation of cleaning and sterilization procedures, tracking the validation lifecycle, evaluating changes and deviations related to validation impact, and supporting authority, customer, and self-inspections.

What qualifications are required for this position?

Candidates are required to have completed studies in the natural sciences (biology, chemistry, pharmacy or comparable), experience in the validation of processes in an aseptic production environment, experience with cleaning and sterilization procedures, initial experience in vaccine production, and business fluency in written and spoken German and English.

What benefits does Takeda offer for this position?

Benefits include an attractive and competitive salary, an open-minded and modern working environment, hybrid working model, 30 vacation days, company pension plan, further education and training, commuting allowance, an attractive relocation package, subsidized canteen, subsidized sports programs, disability insurance, supplementary nursing care insurance, employee discounts, and more.

Where is the job location?

The job is located in Singen, Germany.

What is the working time for this position?

The working time for this position is full-time.

Is there any support for employees living with disabilities?

Yes, Takeda is committed to providing equal employment opportunities and appropriate support for applicants living with disabilities, chronic illness, or neurodiversity during the application process.

Can I apply for this job if I do not speak German?

Business fluency in written and spoken German is required for this position, so it is important to have proficiency in the language to be considered for the role.

Will I be part of a diverse workforce at Takeda?

Yes, Takeda is focused on creating a diverse workforce and has a strong commitment to diversity and inclusion.

Who will I report to in this position?

In this position, you will report to the Team Lead Process Validation.

Better Health, Brighter Future

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society. We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.