Sr. Packaging Engineer

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

        Bachelors 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: 

Email:

Remote Work :

No

Employment Type :

Full-time