Sr. Packaging Engineer

Company Description

Centillion Infotech LLC has served clients since 2017 from our US headquarters in Coppell, Texas, We work with organizations across the United States the technology capability to change a system and the workforce capability to keep it running.

That combination is deliberate. Modernization programs stall when strategy, engineering and staffing sit with three parties who each own a fragment of the outcome.

Job Description

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.

Qualifications

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.

Additional Information

Adam AB

Centillion Infotech LLC

Phone: 469.770.0087

Web: www.centillioninfotech.com

Email:[email protected]