Senior Packaging Engineer: Process Development & Validation Lead

Intellectt Inc; North Haven (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt Inc. seeks a Senior Packaging Engineer to lead packaging process development, qualification, validation, and continuous improvement in a regulated manufacturing environment.

You will manage IQ/OQ/PQ activities, troubleshoot packaging processes, and drive root cause analysis and CAPA implementations to ensure FDA and quality system compliance. The role emphasizes strong problem-solving, project management, and cross-functional communication skills in a safety-focused setting with

Qualifications

• Bachelor's degree in Packaging, Mechanical, Chemical Engineering, or related discipline.
• 3+ years of Packaging Engineering experience.
• Experience in packaging process development, equipment qualification, and IQ/OQ/PQ validation.
• Knowledge of root cause analysis, CAPA, FDA regulations, and quality systems.
• Experience with Lean Manufacturing, Six Sigma, and process improvement.

Responsibilities

• Lead packaging process development, equipment qualification, validation, and continuous improvement in a regulated environment.
• Execute IQ/OQ/PQ, troubleshoot packaging processes, and perform root cause analysis.
• Implement CAPA and maintain technical documentation to ensure compliance with FDA and quality systems requirements.

Skills

Problem solving

Project management

Cross-functional communication

IQ/OQ/PQ validation

CAPA

FDA regulations knowledge

Education

Bachelor's degree in Packaging, Mechanical, or Chemical Engineering

Tools

LEAN Manufacturing

Six Sigma

Job description

Intellectt Inc. seeks a Senior Packaging Engineer to lead packaging process development, qualification, validation, and continuous improvement in a regulated manufacturing environment.

You will manage IQ/OQ/PQ activities, troubleshoot packaging processes, and drive root cause analysis and CAPA implementations to ensure FDA and quality system compliance. The role emphasizes strong problem-solving, project management, and cross-functional communication skills in a safety-focused setting with