Medical Device Packaging Engineer | Validation & ISO 11607

Jobs for Humanity; North Haven (CT); On-site; USD 85,000 - 120,000; Full time

Job summary

Centillion Infotech LLC seeks a Packaging Engineer experienced in medical device packaging, packaging equipment, and validation. You will support packaging design, process validation, equipment qualification, and manufacturing projects while ensuring FDA/ISO compliance.

The ideal candidate has a bachelor's in packaging or related field and 4+ years of packaging/manufacturing engineering experience, with hands-on IQ/OQ/PQ and DOE knowledge.

Qualifications

• Bachelor's degree in Packaging Engineering or related field.
• 4+ years of Packaging/manufacturing engineering experience.
• Experience with medical packaging materials and high-volume packaging equipment (FFS, Bar Sealer, Alloyd).
• Hands-on IQ, OQ, PQ and Process Validation.
• Knowledge of the Process Validation Lifecycle (Process Characterization, OQ, PQ).
• Experience preparing validation protocols, reports, SOPs, and controlled documentation.
• Strong troubleshooting, Root Cause Analysis, and project management skills.
• Experience with cross-functional teams in Manufacturing, Quality, and Regulatory.

Responsibilities

• Design and develop medical device packaging systems and manufacturing processes.
• Lead IQ, OQ, PQ, packaging validation, and equipment qualification activities.
• Develop and review validation protocols, reports, SOPs, and manufacturing documentation.
• Support packaging equipment installation, troubleshooting, and process improvements.
• Ensure compliance with FDA, ISO, GMP, and regulatory requirements.
• Manage packaging projects, timelines, and cross-functional deliverables.
• This role is ideal for a Packaging Engineer with strong experience in medical device packaging, packaging equipment, validation (IQ/OQ/PQ), ISO 11607, and project management.

Skills

Packaging engineering

FDA/ISO compliance

Validation protocols

Project management

Education

Bachelor's in Packaging Engineering

Mechanical/Manufacturing engineering related

Tools

Minitab

DOE

CSV

Job description

Centillion Infotech LLC seeks a Packaging Engineer experienced in medical device packaging, packaging equipment, and validation. You will support packaging design, process validation, equipment qualification, and manufacturing projects while ensuring FDA/ISO compliance.

The ideal candidate has a bachelor's in packaging or related field and 4+ years of packaging/manufacturing engineering experience, with hands-on IQ/OQ/PQ and DOE knowledge.