Senior Specialist, Engineering CQV - Cleaning Validation
Core
Develop, execute, and manage cleaning validation programs for manufacturing equipment in biologics and sterile drug product facilities to ensure regulatory compliance and patient safety.
Role type
Senior Specialist, Engineering CQV (Cleaning Validation)
Builds
Validated cleaning processes and documentation for manufacturing equipment
Domain
Biopharmaceutical manufacturing / Regulatory compliance
Required skills
Cleaning validation principles, health-based exposure limits, worst-case selection, equipment grouping, sampling strategies, risk assessment, technical writing, regulatory knowledge (FDA/EMA/ICH/ASTM), change management, root cause analysis
Preferred skills
Biologics manufacturing experience, sterile drug product operations, facility start-up experience
Technologies
Microsoft Office, validation systems, document management systems
Responsibilities
Develop and execute cleaning validation master plans and protocols; Define scientifically justified cleaning acceptance criteria; Perform worst-case product and equipment assessments; Develop sampling plans for swab and rinse samples; Assess changes and deviations for impact on validated state; Support investigations and corrective actions; Ensure audit-ready documentation; Provide technical guidance to cross-functional teams; Implement process improvements and standardization.
Seniority
Senior, hands-on IC