Cleaning Validation Engineers

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; perform visual inspection assessments and residue sampling (swab and rinse methods); coordinate validation activities with Manufacturing and QA to ensure proper execution during production campaigns; analyze laboratory data for residuals testing and interpret results to determine cleaning process effectiveness; investigate cleaning failures, deviations, and nonconformities and implement CAPAs; partner with Engineering and Operations to optimize cleaning processes and support new equipment commissioning; support change control activities related to equipment modifications, new product introductions, or updated cleaning procedures; write and maintain SOPs related to cleaning validation and verification programs; ensure documentation meets global regulatory expectations, internal quality standards, and audit readiness.