Specialist Qualification Engineering (w/m/d)

Takeda

Linz, Austria
Base: € 3.395,16 grosspmnth; bonus: performance ma...
Hybrid
Gmp compliance in pharmaceutical industry
Qualification of process equipment and cleanrooms
Creation of qualification plans and reports
The role involves independently conducting qualification projects according to cGMP standards for pharmaceutical production facilities

Job Summary

  • The role involves independently conducting qualification projects according to cGMP standards for pharmaceutical production facilities.
  • Candidates will coordinate cross-functional teams throughout the entire asset lifecycle, including FAT, SAT, and commissioning activities.
  • The position offers a comprehensive benefits package including hybrid work options, extensive training opportunities, and a performance-based bonus system.

Matching Summary

The role involves independently conducting qualification projects according to cGMP standards for pharmaceutical production facilities.

Salary

Base: € 3.395,16 gross/month; Bonus: Performance management with bonus system; Benefits: Company pension, health insurance, job bike, free vaccinations

Skills & Requirements

Must-have

  • GMP compliance in pharmaceutical industry
  • Qualification of process equipment and cleanrooms
  • Creation of qualification plans and reports
  • Execution of GxP risk analyses
  • FAT, SAT, and commissioning participation

Nice-to-have

  • Iterative solution development mindset
  • Strong organizational and prioritization skills
  • Experience with CSV (Computer System Validation)
  • Interdisciplinary team collaboration
  • Pragmatic problem-solving approach

Key Requirements

  • 3-5 years experience in pharmaceutical or regulated environment
  • Technical or scientific degree (e.g., Process Engineering, Biotechnology)
  • Fundamental knowledge of FDA/EMA regulations
  • Fluency in German and English languages

Work Rights

Not specified

Tailored Resume

Cover Letter