Packaging Engineer

Role: Packaging Engineer – Medical Devices

Location: New Haven, CT

Duration: 12+ Months

Rate: $45-$50/hr on W2 (Negotiable based on experience)

Description: Our client is seeking an experienced Packaging Engineer to support and optimize packaging operations within a regulated medical device manufacturing environment. The ideal candidate will have strong expertise in packaging process development, equipment qualification, and process validation, including IQ/OQ/PQ. This role will focus on resolving manufacturing challenges, driving continuous improvement, maintaining regulatory compliance, and ensuring packaging processes meet quality and operational requirements.

Responsibilities

• Lead packaging process development, optimization, and improvement initiatives for medical device manufacturing operations.
• Plan and execute packaging equipment qualification and validation activities, including IQ/OQ/PQ.
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues and improve process performance.
• Conduct root cause investigations and develop corrective and preventive actions (CAPA) to address packaging and manufacturing issues.
• Maintain technical documentation, validation protocols, reports, and other quality-related records.
• Ensure packaging processes comply with applicable FDA regulations, quality system requirements, and internal procedures.
• Support packaging equipment implementation, process qualification, and ongoing validation activities.
• Identify opportunities to improve efficiency, product quality, and process reliability using Lean Manufacturing and Six Sigma methodologies.

Required Skills

• 4+ years of Packaging Engineering experience, or equivalent advanced education and relevant experience.
• Experience in packaging process development, equipment qualification, and validation, including IQ/OQ/PQ.
• Experience in medical device, healthcare, pharmaceutical, or other regulated manufacturing environments preferred.
• Knowledge of packaging processes, manufacturing operations, quality systems, and applicable regulatory requirements.
• Familiarity with FDA requirements and quality system compliance in regulated manufacturing.
• Experience with root cause analysis, CAPA, and continuous improvement methodologies.

Education

• Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline required.

Intellectt Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.