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Job Description
Position Summary
The Cleaning Validation Engineer is responsible for developing, executing, and maintaining cleaning validation programs to ensure pharmaceutical manufacturing equipment is cleaned to regulatory and company standards. This role ensures that cleaning processes consistently remove residues of active ingredients, excipients, and cleaning agents to prevent cross‑contamination and maintain product quality. The Cleaning Validation Engineer works closely with Quality Assurance, Manufacturing, Engineering, and R&D teams.
Key Responsibilities
Cleaning Validation Program Management
- Develop and execute cleaning validation protocols, reports, and risk assessments in accordance with cGMP, FDA, EMA, and other regulatory guidelines.
- Establish scientifically justified acceptance criteria for residues and cleaning limits.
- Identify worst‑case product and equipment scenarios using t...