Senior Packaging Engineer

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

Seeking a Senior Packaging Engineer to lead packaging process development, equipment qualification, validation, and continuous improvement in a regulated manufacturing environment. Responsibilities include executing IQ/OQ/PQ, troubleshooting packaging processes, conducting root cause analysis, implementing CAPA, maintaining technical documentation, and ensuring compliance with FDA and quality system requirements.

Required Qualifications:

• Bachelor's degree in Packaging, Mechanical, Chemical Engineering, or a 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.
• Medical device, pharmaceutical, or other regulated manufacturing experience preferred.
• Strong problem-solving, project management, and cross-functional communication skills.

Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Intellectt Inc. is an Equal Opportunity Employer.

Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.