This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated/implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.
BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) having a minimum of 4+ years related experience or 3+ years related experience w/ an advanced degree or demonstrated performance within a technical department within the organization.