Packaging Engineer Salary in St. Louis, MO

The Quality Engineer is responsible for developing, reviewing, and managing the execution of validation activities, and ensuring that the qualifications are consistent with the user's/manufacturer's requirements and quality standards. Interact cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and MaintenanceCreate and execute protocols for equipment, methods, analytical instrumentation, and cleaning, process controls, and facility including but not limited to FAT/SAT/IOQ and PQ documentsUtilize GDP in a GMP atmosphere while generating protocols and reviewing documents. Review and generate closing reports for executed protocolsCreate validation schedules, coordinate execution efforts with contractors, production operators, production engineers, customers, and quality assurance staff membersWork through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilitiesDevelop/Establish an overall plan for qualifying new equipment or new/upgraded facility and establishing the proper controls for the introduction of equipment/facility and/or changes under proper quality standards (e.g. FDA, EU, ISO, ISPE, etc.)Identify and establish revalidation requirementsWrite and execute qualification packages, technical reports, and validation master plansDevelop cleaning validation protocols for equipment and facilitiesDevelop clean/dirty hold times This is a Hybrid role requiring 3 days per week onsite. Minimum Qualifications:Bachelor's Degree in Biomedical Engineering, Chemical Engineering, Chemistry, or Biochemistry Preferred Qualifications:2+ years of experience in quality or a quality support role2+ years of experience with equipment or validation, in a cGMP manufacturing setting or related industrial laboratory environmentAbility to utilize GDP during document creation and reviewWorking knowledge of current regulatory guidelines and standardsAbility to apply and incorporate regulatory standards, rules, and guidance. (e.g. FDA, EU, ISO, ISPE, etc.) Experience in a fast-paced environment with the ability to adjust to changing prioritiesDetailed-oriented work standardsSound understanding of Quality Risk Management conceptsRSREMD