Responsible Validation Specialist (f/m/x)

Full Time
Vienna, VA
Posted
Job description

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Job Description

About the role:

As part of the local PS (Process Science) - MSV (Manufacturing Sciences Vienna) team, you will be responsible for process validation as cornerstone of process stability. Developing new validation strategies for your projects and their operational execution implementation is your core task. You will be in close contact with the manufacturing/quality organizations and global stakeholders to ensure validated, robust and stable manufacturing processes.


How you will contribute:

  • Process Life Cycle Management
  • Process validation (PPQ - Process Performance Qualification) under consideration of continuous process verification (CPV - Continued Process Verification) congruently
  • Risk management according to Quality by Design (QbD) Principles
  • Supporting process improvement and robustness initiatives
  • Process validation statements for process deviations/root cause analysis
  • Evaluation of changes (manufacturing processes, analytical tests, and materials)

What you bring to Takeda:

  • University degree in biotechnology, pharmaceutical sciences, process engineering, chemistry or equivalent
  • Experience in a comparable position, ideally in the chemical, pharmaceutical, or food industry
  • Profound knowledge of QbD and process validation
  • Analytical and critical thinking personality and problem solving capability
  • Perfect communication skills (German and English) and self-confident, assertive demeanor
  • Experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)
  • Green Belt certification, Six and Lean Sigma, DMAIC, Data Analysis are preferred

What Takeda can offer you:

A competitive remuneration package with a minimum salary of € 3.557,47 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications.

  • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten

  • Work @ home depending on the position / department

  • Comprehensive training programs

  • In-house job rotation program

  • In-house Canteen with discounts or meal vouchers

  • Works council (events, festivals, shopping vouchers, etc.)

  • Employee Referral Program

  • Employee Recognition Program

  • Takeda Resource Groups

  • Medical checkups

  • Free vaccination program

  • Fitness Center

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 race, color, 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.

Locations

AUT - Wien - Industriestrasse 67

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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