Sr. Cleaning Validation Engineer II

Role Summary

Sr. Cleaning Validation Engineer II

Responsibilities

• Manage validation programs and projects.
• Develop validation strategies to test equipment and processes in compliance with domestic and international GMP regulations.
• Create and maintain validation life cycle documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrix.
• Provide technical assessments for CAPAs, deviation, and change control management.
• Troubleshoot cleaning and steam sterilization issues to ensure smooth manufacturing operation.
• Collaborate with stakeholders to establish project timelines and scopes.
• Review and approve validation deliverables including project plans, protocols, reports, risk assessments, and test scripts.
• Lead continuous improvements into validation activities and policies.
• Implement best practices for validation programs across facilities.
• Support new product rollout by validating new systems and processes during Tech Transfer.
• Represent the organization in contractual or project matters, interacting with senior internal and external personnel.
• Provide validation expertise to regulatory affairs when responding to governmental regulatory bodies.

Qualifications

• Required: Bachelor‚Äôs degree in Industrial Chemical Engineering, Chemical Engineering, or related field, plus 7 years of related experience.
• Required: experience preparing cleaning validation plans aligned with organizational policy; preparing cleaning risk assessments for new product introduction or existing product introduced to a new system based on toxicology data;
• Required: develop and execute Cleaning Validation (CV) testing Protocols to validate cleaning processes (CIP, COP);
• Required: develop and execute IQ/OQ/PQ protocols to qualify sterilization systems (autoclaves and SIP) and other GMP equipment.

Skills

• Validation program management
• GMP compliance and regulatory affairs collaboration
• Technical writing for protocols and reports
• CAPA, deviation, and change control management
• Troubleshooting cleaning and sterilization processes
• Project planning and stakeholder collaboration

Education

• Bachelor‚Äôs degree in Industrial Chemical Engineering, Chemical Engineering, or related field

Additional Requirements

• Up to 5% domestic travel required.
• Up to 40% remote work allowed.