Senior Packaging Engineer: GMP Validation & Process

Intellectt Inc; North Haven (CT); On-site; USD 90,000 - 140,000; Full time

Job summary

Intellectt Inc. is seeking a Senior Packaging Engineer to support and improve packaging operations in medical device or regulated manufacturing environments.

The role focuses on packaging process development, equipment qualification, validation, quality compliance, and continuous improvement. Responsibilities include leading IQ/OQ/PQ validation, conducting root cause analyses, and maintaining thorough validation records.

Qualifications

• Experience in regulated manufacturing; medical device, healthcare, or pharmaceutical experience preferred.
• Leads packaging equipment qualification and IQ/OQ/PQ validation activities.
• Knowledge of FDA regulations and quality systems.
• Maintains validation records and technical documentation.

Responsibilities

• Develop and improve packaging processes and manufacturing operations.
• Lead packaging equipment qualification and IQ/OQ/PQ validation activities.
• Perform root cause analysis and implement CAPA solutions.
• Ensure compliance with FDA regulations and applicable quality system requirements.
• Maintain technical documentation and validation records.
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.
• Drive continuous improvement using Lean Manufacturing and Six Sigma methodologies.
• Experience in regulated manufacturing; medical device, healthcare, or pharmaceutical experience preferred.

Skills

Lean Manufacturing

Six Sigma

Project leadership

Technical communication

Cross-functional collaboration

Problem-solving

Job description

Intellectt Inc. is seeking a Senior Packaging Engineer to support and improve packaging operations in medical device or regulated manufacturing environments.

The role focuses on packaging process development, equipment qualification, validation, quality compliance, and continuous improvement. Responsibilities include leading IQ/OQ/PQ validation, conducting root cause analyses, and maintaining thorough validation records.