Position Overview:
The Packaging Engineer is responsible for supporting packaging operations through process validation, equipment qualification, change management, and continuous improvement activities. This role provides technical leadership for packaging processes, equipment, and materials to ensure compliance with quality, regulatory, and manufacturing requirements while supporting operational efficiency and product quality.
What you will do:
- Lead packaging process and equipment qualifications, including IQ, OQ, and PQ activities.
- Develop, execute, and document validation protocols and reports for packaging processes, equipment, and materials.
- Manage packaging-related CAPAs, nonconformances, investigations, and corrective actions.
- Support change control activities, evaluating the impact of process, material, equipment, and supplier changes.
- Provide technical support to manufacturing operations, including troubleshooting and resolution of packaging-related issues.
- Lead qualification efforts for alternative materials, suppliers, and packaging components to mitigate supply risks.
- Support installation, commissioning, and validation of new packaging equipment.
- Drive continuous improvement initiatives to enhance quality, efficiency, and cost performance.
- Ensure packaging processes and temporary deviations comply with applicable quality system and regulatory requirements.
- Maintain packaging specifications, validation records, engineering documentation, and technical reports.
- Collaborate with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and suppliers to support business objectives.
- Support audits and inspections by providing packaging-related technical expertise and documentation.
Skills for Success:
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Engineering, or related technical discipline required.
- 3-5 years of packaging engineering experience in a regulated manufacturing environment, preferably medical devices required.
- Experience with process validation, equipment qualification, change control, and CAPA systems.
- Knowledge of packaging equipment, materials, manufacturing processes, and design software (such as SolidWorks).
- Familiarity with FDA Quality System Regulation, ISO 13485, and ISO 11607 requirements.
- Strong problem-solving, project management, and technical documentation skills.
- Excellent written and verbal communication skills.
