In this position you will define, execute, review/approve and summarize equipment, process, facility and sterilization (EtO, gamma) validation documentation including investigations into failures; use quality engineering concepts to monitor, support and critically review changes or issues to existing product lines and/or critical processes; review and approve appropriate controlled documentation (ex. validation protocols and reports, DMR related documents, nonconformances, etc.); insure data is reviewed and trends are investigated in a manner to ensure product quality. You will create process, equipment, sterilization and facility validation plan/protocols and reports that are comprehensive, clearly written and technically sound and execute to plan; manage process and equipment changes to maintain product quality attributes; coordinate and supervise the generation and execution of outside contract validation study protocols and summary reports; participate in risk identification and assessment (FMEA) actions for new/changed equipment and processes; execute validation master plans and reports for product, facility and critical processes.
BS in Life Sciences or Engineering preferred with 3-5 years of Validation or Quality Engineering experience. Background in pharmaceutical, biotechnology and/or chemistry production and Certified Quality Engineer or Professional Engineer preferred. Experience in medical device, drug and/or API equipment and process validation activities. Excellent organizational ability, capability to manage multiple, dynamic cross functional projects simultaneously. Experience with sterilization (EtO, gamma, filter sterilization, aseptic fill) equipment and process validation activities.