This role ensures all computerized systems meet strict validation, compliance, and regulatory requirements within a pharmaceutical environment
Job Summary
This role ensures all computerized systems meet strict validation, compliance, and regulatory requirements within a pharmaceutical environment.
The position involves developing and executing validation activities including URSs, DQ, FAT/SAT, IQ/OQ protocols, and reports while supervising vendors.
Takeda offers a competitive salary range of €57,800 - €79,420 along with comprehensive benefits including private medical insurance and generous vacation time.
Matching Summary
This role ensures all computerized systems meet strict validation, compliance, and regulatory requirements within a pharmaceutical environment.
Salary
Base: €57,800.00 - €79,420.00; Bonus/Equity: Performance-based bonuses included; Benefits: Employer-funded private medical insurance, retirement plan, and 26 vacation days
Skills & Requirements
Must-have
Minimum 3 years CSV experience in pharma
Bachelor's degree in Engineering or Science
Knowledge of 21 CFR Part 11 and data integrity
Experience writing validation plans and protocols
Ability to work in regulated environment
Nice-to-have
Familiarity with Kneat Paperless Validation tool
Experience with API or Drug Product manufacturing
Strong technical writing and communication skills
Self-motivated with continuous improvement mindset
Experience supporting CAPEX projects
Key Requirements
Bachelor's degree in Engineering, Science, or equivalent
Minimum 3 years experience in CSV within pharmaceutical industry