About this role
Your responsibilities Lead the design, layout, and set-up of a new non-sterile packaging room, including equipment selection, installation, and process flow. Develop, execute, and document cleaning validations for the packaging area, equipment, and associated processes. Plan and execute non-sterile packaging projects for the U.S. market; support worldwide (WW) packaging projects as applicable. Establish and qualify packaging processes and equipment (IQ/OQ/PQ) and support process validations. Author, maintain, and improve controlled technical documentation such as work instructions, procedures, protocols, reports, bills of materials, and routers in Medartis MRP systems. Troubleshoot and resolve a variety of complex product and process performance issues within the packaging operation. Drive continuous improvement activities to enhance quality, throughput, cost, and reliability of packaging processes. Participate in and/or lead on-the-job (OTJ) training of operators for packaging processes and equipment. Communicate (written and verbal) clear direction to the operations team relative to packaging processes. Support technical questions from operations, quality, and suppliers. Be able to represent Medartis as an SME during audits Coordinate tooling, material, and equipment needs with procurement and cross-functional partners. Ensure packaging operations comply with applicable regulatory and quality system requirements (e.g., FDA QSR / 21 CFR 820, ISO 13485). Travel: Some local/global traveling required to support projects when needed. Your qualifications Bachelor’s degree in engineering (Mechanical, Manufacturing, Industrial, Packaging, Biomedical) or a related technical field required. At least 5 years of manufacturing engineering experience required, with a minimum of 3 years in a medical device company. Demonstrated experience setting up and executing cleaning validations required. Demonstrated experience executing non-sterile packaging projects in the U.S. required; experience with worldwide (WW) packaging projects is a plus. Experience setting up a packaging room, cleanroom, or controlled manufacturing area is strongly preferred. Working knowledge of process and equipment validation (IQ/OQ/PQ) and validation protocol/report authoring required. Sound understanding of concepts and principles for manufacturing in new product processes required. Working knowledge in areas such as Quality, Operations, and New Product Introduction required. Knowledge of medical device regulations and standards (FDA QSR / 21 CFR 820, ISO 13485; ISO 11607 for packaging a plus) required. Strong problem-solving skills with the ability to analyze and resolve complex product and process issues. Ability to prioritize multiple complex project assignments and complete work in a timely manner. Ability to effectively work and communicate with any cross-functional team to complete critical project tasks.