Packaging Engineer

G3 Soft Inc; Connecticut; On-site; USD 110,000 - 140,000; Full time

Job summary

G3 Soft Inc is seeking an experienced Packaging Engineer to support and improve packaging operations for medical device manufacturing. You will lead packaging process development and qualification/validation (IQ/OQ/PQ) and work with cross-functional teams across Manufacturing, Quality, Regulatory, Operations, and Engineering.

The ideal candidate has a 7+ year background in packaging engineering within regulated environments, strong knowledge of validation, quality systems, and regulatory

Qualifications

• Bachelor's degree in a packaging or related engineering field is required.
• 7+ years of Packaging Engineering experience in regulated environments is required.
• Strong knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
• Excellent problem-solving, project leadership, communication, and cross-functional collaboration skills.

Responsibilities

• Support and improve packaging operations for medical device manufacturing.
• Lead packaging process development and equipment qualification/validation (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.
• Investigate production issues, perform root cause analysis, and implement CAPA.
• Maintain technical documentation and ensure compliance with FDA and quality standards.
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.

Skills

Packaging validation

Lean Manufacturing

Six Sigma

Cross-functional collaboration

Problem-solving

Project leadership

Education

Bachelor's degree in Packaging Engineering/Packaging Science/Mechanical/Chemical Engineering or related engineering discipline

Job description

• Support and improve packaging operations for medical device manufacturing.
• Lead packaging process development and equipment qualification/validation (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams.
• Investigate production issues, perform root cause analysis, and implement CAPA.
• Maintain technical documentation and ensure compliance with FDA and quality standards.
• Drive continuous improvement initiatives 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.
• Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments is preferred.
• Strong knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.
• Excellent problem-solving, project leadership, communication, and cross-functional collaboration skills.