Cleaning Validation & Commissioning Specialist
Core
Plan and execute commissioning, qualification, and validation (CQV) for equipment, facilities, utilities, and processes to ensure robust, high-quality products in line with regulatory and quality objectives.
Role type
Senior IC Cleaning Validation & Commissioning Specialist
Builds
Validated manufacturing systems, equipment, and processes for pharmaceutical, medical device, or related industries
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CQV protocol development, risk management (FMEA), change control management, cleaning validation sampling, regulatory compliance knowledge, project leadership, team supervision
Preferred skills
Supervisory experience, managing 5+ concurrent projects, knowledge of API/Bulk Drug/Finished goods regulations, background in healthcare/nutritional/medical device/pharma industries
Technologies
Validation Master Plan, ccRA, FMEA tools, EHS 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; prepare area reports and presentations; support staff training on new equipment/processes.
Seniority
Senior, hands-on IC with supervisory capabilities
