Cleaning Validation & Commissioning Specialist
Core
Plan and execute commissioning, qualification, and validation (CQV) for new/modified equipment, facilities, utilities, and processes to ensure robust, high-quality products in line with regulatory requirements.
Role type
Senior IC validation and commissioning specialist
Builds
Validated manufacturing systems, equipment, and processes for pharmaceutical/healthcare products
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Risk management (FMEA, ccRA), CQV protocol development, change control management, cleaning validation sampling, project leadership, regulatory compliance knowledge
Preferred skills
Supervisory experience, multi-project management (5+), knowledge of API/Bulk Drug manufacturing regulations, technical background in healthcare/pharma
Technologies
FMEA tools, Validation Master Plan systems, Change Control systems
Responsibilities
Develop and execute CQV test protocols; lead risk management activities and periodic reviews; coordinate and execute cleaning validation sampling and documentation; generate and process change requests; lead special projects in cleaning validation; support staff training on new equipment/processes.
Seniority
Senior, hands-on IC with potential supervisory duties