Job Description

Job Description

Responsible for supporting and improving packaging operations within medical device manufacturing. Lead packaging process development, equipment qualification, and validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Collaborate with cross-functional teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA regulations and quality system requirements. Conduct root cause investigations, develop CAPA solutions, maintain technical documentation, and drive operational excellence through Lean Manufacturing and Six Sigma methodologies.

Key Skills

• Packaging process development, packaging operations, equipment qualification, and process validation, including IQ/OQ/PQ.
• Root cause analysis, CAPA development, problem-solving, and continuous improvement.
• Lean Manufacturing, Six Sigma methodologies, and operational excellence.
• Manufacturing process improvement, quality systems, regulatory compliance, and technical documentation.
• Cross-functional collaboration, project leadership, and technical communication.

Required Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
• 7+ years of Packaging Engineering experience, or an equivalent combination of an advanced degree and relevant experience.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.

Additional Skills

• Experience in medical device, healthcare, pharmaceutical, or other regulated manufacturing environments is preferred.
• Ability to collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues and implement process improvements.
• Experience supporting packaging equipment and process validation activities and maintaining compliance with FDA and applicable quality system requirements.

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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