Sr Packaging Engineer

Intellectt Inc; North Haven (CT); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid time off as required by law

Job summary

Intellectt Inc is seeking an experienced Packaging Engineer to lead packaging process development for medical device manufacturing. You will qualify equipment (IQ/OQ/PQ), drive improvements, and collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.

A Bachelor's degree in packaging or related engineering and 7+ years of experience in regulated environments are required; Lean/Six Sigma experience is a plus.

Qualifications

• Bachelor's degree in packaging/engineering required.
• 7+ years of Packaging Engineering experience in regulated environments preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.

Responsibilities

• Support and improve packaging operations for medical device manufacturing.
• Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve issues and drive improvements.
• Perform root cause investigations and develop CAPA solutions; maintain technical documentation.

Skills

Problem solving

Project leadership

Technical communication

Cross-functional collaboration

Education

Bachelor's degree in Packaging Engineering / related Engineering

Job description

• Responsible for supporting and improving packaging operations for medical device manufacturing. Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA and quality system requirements.
• Perform root cause investigations, develop CAPA solutions, maintain technical documentation, support packaging equipment and process validation, and drive operational excellence using Lean Manufacturing and Six Sigma methodologies. Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills are required.

Qualification

• Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
• 7+ years of Packaging Engineering experience (or equivalent advanced degree and relevant experience).
• Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements

Pay Scale-

Anticipated hourly pay range: specific range such as ($40/hr to $45/hr).

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