Also required is 5 years of experience: working in computer system validation (CSV) using GAMP5 methodology tools, and validating software systems, including enterprise management systems, manufacturing systems, and laboratory systems; utilizing 21 CFR Part 11, Annex 11, ICH E6R2, GAMP5 regulations and guidelines, as well as risk management tools, to execute validation projects; and reviewing and/or approving validation documents, including change control, deviation, and CAPA records. Requires Bachelor’s or foreign equivalent degree in pharmaceutical engineering, computer science or related field with 5 years of experience in the job offered or 5 years of experience working as a validation or quality professional in the pharmaceutical, biotech, or related life-sciences industry.