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.