Packaging Engineer: Validation, Equipment & Improvement

Argon Medical Devices Inc; Athens (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Argon Medical Devices Inc is seeking a Packaging Engineer to oversee packaging operations and ensure compliance with regulatory requirements. You will lead IQ/OQ/PQ activities, validate packaging processes, and manage CAPAs and change controls.

The role requires 3–5 years in packaging engineering within a regulated manufacturing environment, preferably medical devices, and knowledge of ISO 11607, ISO 13485, and FDA QSR. SolidWorks is a plus, with focus on quality and continuous improvement.

Qualifications

• Bachelor's degree in Packaging Engineering or related technical field.
• 3–5 years of packaging engineering experience in a regulated manufacturing environment (medical devices preferred).
• Experience with process validation, equipment qualification, change control, and CAPA systems.
• Knowledge of packaging equipment, materials, and design software (SolidWorks).
• Familiarity with FDA Quality System Regulation, ISO 13485, and ISO 11607 requirements.

Responsibilities

• Lead packaging process and equipment qualifications (IQ, OQ, PQ).
• 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 and evaluate impact of changes.
• Provide technical support to manufacturing operations and troubleshoot packaging 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 to enhance quality, efficiency, and cost performance.
• Ensure packaging processes and deviations comply with quality and regulatory requirements.
• Maintain packaging specifications, validation records, and engineering documentation.

Skills

Packaging engineering

Process validation

Regulatory compliance

Documentation skills

SolidWorks

Project management

Education

Bachelor's degree in Packaging Engineering

Tools

SolidWorks

Job description

Argon Medical Devices Inc is seeking a Packaging Engineer to oversee packaging operations and ensure compliance with regulatory requirements. You will lead IQ/OQ/PQ activities, validate packaging processes, and manage CAPAs and change controls.

The role requires 3–5 years in packaging engineering within a regulated manufacturing environment, preferably medical devices, and knowledge of ISO 11607, ISO 13485, and FDA QSR. SolidWorks is a plus, with focus on quality and continuous improvement.