Senior Packaging Engineer

Job Summary

We are seeking a Sr. Packaging Engineer to support and improve packaging operations in a regulated manufacturing environment, preferably within the medical device industry. The role focuses on packaging process development, equipment qualification, validation, and continuous improvement while ensuring compliance with FDA and quality system requirements.

Responsibilities

• Lead packaging process development, improvement, and equipment qualification activities.
• Support packaging validation, including IQ/OQ/PQ.
• Conduct root cause investigations and implement CAPA solutions.
• Maintain technical documentation and ensure compliance with regulatory and quality requirements.
• Collaborate with Manufacturing, Quality, Regulatory, and Engineering teams to resolve production issues.
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.

Required Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
• 7+ years of relevant Packaging Engineering experience.
• Experience with packaging process development, validation, and equipment qualification.
• Knowledge of root cause analysis, CAPA, quality systems, and regulatory requirements.
• Strong problem-solving, technical communication, and cross-functional collaboration skills.

Preferred Qualifications

• Experience in medical device, pharmaceutical, healthcare, or other regulated manufacturing environments.
• Knowledge of FDA requirements, Lean Manufacturing, and Six Sigma.
• Experience with packaging equipment troubleshooting and continuous improvement.

Work Requirements

• Ability to work onsite in North Haven, CT.

Pay Rate: $35-40/hr on W2

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
• Retirement Benefits: A 401(k)-retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws

Equal Employment Opportunity

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.

Application

Interested candidates who meet the qualifications are encouraged to apply with an updated resume highlighting their Packaging Engineering, validation, and regulated manufacturing experience