Packaging Manufacturing Engineer – Non‑Sterile, GMP‑Focused

Medartis Inc. - United States; Warsaw (IN); Sur place; USD 80 000 - 105 000; Plein temps

Résumé du poste

Medartis Inc. in Warsaw, IN seeks a Manufacturing Engineer to lead the setup of a new non-sterile packaging room and establish compliant packaging operations. You will develop cleaning validations, document procedures, and guide projects for the U.S. market with global support.

The role requires hands-on problem solving, adherence to FDA QSR/21 CFR 820 and ISO 13485, and collaboration across operations, quality, and procurement. Onsite with travel as needed.

Qualifications

• Bachelor's degree in engineering or related technical field.
• At least 5 years engineering experience in manufacturing, 3 in medical devices.
• Experience setting up a packaging room and cleanroom preferred.
• Experience with IQ/OQ/PQ validation and regulatory requirements.
• Experience with cleaning validations for packaging.

Responsabilités

• Lead the design, layout, and setup of a new non-sterile packaging room.
• Develop, execute, and document cleaning validations for packaging area, equipment, and processes.
• Plan and execute non-sterile packaging projects for the U.S.; support worldwide 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 complex product and process issues within the packaging operation.
• Drive continuous improvement to enhance quality, throughput, cost, and reliability of packaging processes.
• Participate in and/or lead on-the-job training of operators for packaging processes and equipment.
• Communicate 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 FDA QSR / 21 CFR 820, ISO 13485; travel as needed.

Connaissances

Packaging engineering

Process validation

Troubleshooting

Cross-functional collaboration

Documentation

Formation

Bachelor's degree in engineering (Mechanical/Manufacturing/Biomedical)

Description du poste

Medartis Inc. in Warsaw, IN seeks a Manufacturing Engineer to lead the setup of a new non-sterile packaging room and establish compliant packaging operations. You will develop cleaning validations, document procedures, and guide projects for the U.S. market with global support.

The role requires hands-on problem solving, adherence to FDA QSR/21 CFR 820 and ISO 13485, and collaboration across operations, quality, and procurement. Onsite with travel as needed.