Validation Engineer

Job description

Job Description Responsible for the execution of all qualification/validation activities, excluding process validation, at the Active Pharmaceutical Ingredient (API) manufacturing sites of Agilent Technologies Nucleic Acid Solutions Division. Generating and reviewing validation study documentation including validation plans, change controls, protocols, requirements specifications, asset induction requests, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements. Execute validation studies in support of engineering, manufacturing, process development, facilities, IT, quality control, and quality assurance. Manage or support the validation program. Suggests, develops and/or implements improvements to the program to ensure it maintains compliance with current regulatory and industry expectations. Supports validation deliverables related to Equipment, Instruments, Facilities, Utilities, Cleaning, Computerized Systems and ongoing validations, as needed. Generates, revises and executes validation documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR, ICH, Eudra...