About The Role

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.