Job Summary
Seeking a Senior Packaging Engineer to support and improve packaging operations in medical device or regulated manufacturing environments. The role focuses on packaging process development, equipment qualification, validation, quality compliance, and continuous improvement.
Key Responsibilities
- Develop and improve packaging processes and manufacturing operations.
- Lead packaging equipment qualification and IQ/OQ/PQ validation activities.
- Perform root cause analysis and implement CAPA solutions.
- Ensure compliance with FDA regulations and applicable quality system requirements.
- Maintain technical documentation and validation records.
- Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.
- Drive continuous improvement 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 packaging engineering experience or equivalent advanced degree and relevant experience.
- Knowledge of packaging process development, validation, equipment qualification, and quality systems.
- Experience in regulated manufacturing; medical device, healthcare, or pharmaceutical experience preferred.
- Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills.
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.