Manufacturing Scientist Process Validation with

vor 3 Wochen

Wien, Österreich Takeda Pharmaceutical Vollzeit

**About the role**:
As part of the local Process Science team Hematology & Biosurgery, you will connect science and manufacturing focusing on quality, compliance, and risk management. You will contribute to ensure process consistency and product quality in a dynamic manufacturing environment, in close contact with site manufacturing, quality, and our global network.

**How you will contribute**:

- Support and perform process validation throughout the product lifecycle including QbD risk assessment, process performance qualification (PPQ), and continued process verification /process monitoring & trending
- Perform PPQ including strategy design, plan preparation, and report authoring
- Perform PPQ supporting studies and related studies (e.g., life cycle validations)
- Support authority submission teams and responses to authority requests with process expertise and data analyses
- Represent at internal and external authority audits
- Provide expert knowledge in projects and technical problem solving
- Support process stabilization & standardization activities and process improvement
- Drive business process improvement as digitalization and automation

**What you bring to Takeda**:

- University degree in biotechnology, biochemistry, pharmaceutical sciences, process engineering, chemistry, or related area of natural sciences
- Ability to take the initiative and work independently while developing and maintaining effective communication with the stakeholders without formal authority
- Good collaborator with excellent interpersonal communication skills
- Ability to present complex topics in front of multidisciplinary audiences and authorities
- Innovative and creative thinking
- Experience in the pharmaceutical industry and knowledge of GMP with focus on protein biochemistry, bioprocessing, and PPQ & QbD requirements preferred
- Knowledge related to Six Sigma, DMAIC, Data Analysis would be a major plus
- A sense of humor and an ability to manage stressful situations will bring you a long way

**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
- 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 72

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time

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