Senior Packaging Engineer

JobDiva, Inc.; Hoboken (NJ); On-site; USD 85,000 - 120,000; Full time

Job summary

JobDiva, Inc. seeks an experienced Packaging Engineer to support and improve packaging operations for medical device manufacturing in Hoboken, NJ.

You will 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, and ensure FDA compliance.

Qualifications

• Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
• 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.

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 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.

Skills

Root cause analysis

CAPA

Lean manufacturing

Six Sigma

Packaging process development

IQ/OQ/PQ

Education

Bachelor's Degree in Packaging Engineering/Packaging Science/Mechanical/Chemical Engineering

Job description

Responsibilities:

• 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.

Requirements:

• Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
• 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.