About this role
About the Role Novartis seeks a Validation Expert (m/f/d) based in Kundl, Austria. You will help ensure pharmaceutical products are manufactured to the highest quality by planning and creating validation documents, supporting validation strategies for processes and cleaning procedures, and performing risk analyses including Extractables and Leachables (E&L) for Drug Substance processes. This is a dynamic role with a direct impact on process improvement and patient safety, and it is a fixed-term position for 2 years. Hybrid work arrangement (#LI-Hybrid) applies. What You'll Do
- Coordinate and conduct process- and cleaning-validation projects in compliance with cGMP requirements.
- Create and maintain validation plans, protocols and reports for various manufacturing processes.
- Support definition of validation strategies for processes and cleaning procedures.
- Perform risk analyses, including E&L for Drug Substance processes.
- Support the full process-validation lifecycle from planning to execution.
- Create and update local SOPs and work instructions in the validation field.
- Collaborate with interdisciplinary project teams on validation projects. What We're Looking For
- University degree (minimum Bachelor of Science), ideally in biotechnology, chemistry, pharmacy, chemical engineering or related natural science.
- 1–3 years of professional experience in production, Manufacturing Science and Technology, technical development, quality or analytics.
- Detailed understanding of manufacturing processes and related process equipment.
- Solid understanding of quality systems and regulatory requirements from various health authorities.
- Experience in creating and reviewing technical reports and validation documentation.
- Very good German and English language skills. Nice to Have
- Not specified Compensation & Benefits
- Expected annual base salary range: EUR 60,978 - EUR 89,300 per year.