Senior Packaging Engineer

Intellectt INC

North Haven, CT
3 days ago

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Skills

Change Controlunmatched
Code of Federal Regulationsunmatched
Computer Systemsunmatched
Cross-Functionalunmatched
Document Managementunmatched
Documentationunmatched
Engineeringunmatched
Equipment Validationunmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Minitabunmatched
Process Improvementunmatched
Process Validationunmatched
Product Packagingunmatched
Project/Program Managementunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
United States Department of Energy (DOE)unmatched
Validation Planunmatched

Description

Hi ,

Hope you are doing good,

My name is Ayaan, and I'm a Senior Recruiter at Intellectt Inc. I came across your profile and believe your experience could be a good match for an exciting opportunity I'm currently working on.

If you're interested, please send your updated resume to ayaan.f@intellectt.com

Title: Sr. Packaging Engineer
Location: North Haven, CT
Durations: Long Term

Job Summary
We are seeking a Packaging Engineer with experience in Medical Device packaging, packaging equipment, and packaging validation. The ideal candidate will support packaging design, process validation, equipment qualification, and manufacturing projects while ensuring compliance with FDA and ISO standards.

Required Skills

Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a 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 experience with 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 working with cross-functional teams in Manufacturing, Quality, and Regulatory.

Preferred Skills

Packaging system design and validation per ISO 11607-1 & ISO 11607-2.

Knowledge of ASTM and ISTA packaging standards.

Experience with DOE (Minitab).

Computer System Validation (CSV).

Medical Device Change Control.

Custom equipment validation.

Knowledge of FDA 21 CFR Part 820, GMP, and Medical Device Quality Systems.

Key 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.