Senior Validation Specialist (f/m/d)


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Job Description

About the role:

As Senior Validation Specialist, you will be part of the local PS (Process Science) - MSV (Manufacturing Sciences Vienna) team, responsible for controlling of the process stability and evaluation of  product quality. You will be in charge of developing validation strategies and their operative execution as well as be in close contact with the site’s manufacturing/quality organizations and global stakeholders to ensure an appropriate level of expertise provided to the site’s operations to guarantee validated, robust and stabile manufacturing processes.


How you will contribute:

  • Process Life Cycle Management for Vienna products

  • Assurance of robustness and stability of Vienna manufacturing processes

  • Process Installation, Process Performance Qualification (PPQ) and Continous Process Verification (CPV)

  • Development of qualification/validation strategies

  • Leadership of interdisciplinary teams in validation projects

  • Authoring of validation documents

  • Quality by design (risk management) and development of control strategy

  • Presentation and defense of PPQ-strategies and -documentation for internal/external audits

  • Support of process improvement and robustness initiatives

  • Process validation statements for process deviations / Root-cause analysis

  • Evaluation of changes (manufacturing processes, analytical testing, and materials)

  • Product related review and approval of manufacturing and validation documents

  • Mentoring & training for colleagues

  • Evaluation of suitability of new technologies / Forecasts and projections

  • Assurance of all internal and external requirements regarding GMP & EHS

What you bring to Takeda:

  • University degree in biotechnology, pharmaceutical sciences, process engineering, chemistry or equivalent

  • Experience in the pharmaceutical industry

  • Profound knowledge of QbD and process validation

  • Profound knowledge and expertise in biochemistry, protein purification, and engineering principles

  • Excellent communication skills in German and English

  • Experience in interacting with regulatory authorities and official bodies (FDA, EMA, etc.)

  • Knowledge related to GMP-requirement, Six and Lean Sigma, DMAIC, Data Analysis is preferred

  • Analytical and critical thinking personality and problem solving capability

  • Innovative, creative and pragmatic orientation

  • Leadership and managerial skills

  • Green Belt certification or equivalent preferred

  • Experience in technical problem solving and statistical process control

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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