Description
The QA Validation Analyst/Engineer will plan, approve, and execute validation activities for equipment, utilities, facilities, cleaning processes, automated systems, and laboratory instruments in a manufacturing plant. The role supports the validation quality program, regulatory and third-party audits, CAPA investigations, standard operating procedures, and preventive and corrective actions, with possible supervision of contract validation resources. It requires proficiency with Kaye Validator and TempTales, temperature and relative-humidity mapping, sterilization and cleaning validations, and 3–5 years of experience; a bachelor's degree in Biology, Chemistry, or Engineering is preferred, along with quality, compliance, and API or bulk-drug manufacturing knowledge.
