Job Description

Job Description

Job Title: Packaging Engineer

Location: North Haven, CT

Work Arrangement: Onsite

Experience Required: 3+ years

Employment Type: Contract

Job Description:

The Senior Packaging Engineer will be responsible for supporting and improving packaging operations for medical device manufacturing. The role involves leading packaging process development, equipment qualification, and validation activities, including IQ/OQ/PQ.

The engineer will collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA regulations and quality system requirements.

Key Responsibilities:

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• Lead packaging process development, optimization, and improvement initiatives.
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• Perform packaging equipment qualification and process validation, including IQ/OQ/PQ.
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• Conduct root cause investigations and develop CAPA solutions.
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• Ensure compliance with FDA requirements and applicable quality systems.
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• Maintain technical documentation and validation records.
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• Support packaging equipment troubleshooting and manufacturing process improvements.
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• Apply Lean Manufacturing and Six Sigma methodologies to improve operational efficiency.
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• Collaborate with cross-functional teams to resolve technical and production challenges.
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Required Qualifications:

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• Bachelor’s degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
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• 3+ years of relevant Packaging Engineering experience.
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• Experience in medical device, pharmaceutical, healthcare, or other regulated manufacturing environments.
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• Strong knowledge of packaging validation, equipment qualification, manufacturing processes, and quality systems.
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• Experience with IQ/OQ/PQ, CAPA, and root cause analysis.
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• Strong problem-solving, technical documentation, project leadership, and communication skills.
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Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

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.

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