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Senior Packaging Engineer

2 months ago

Exton, Pennsylvania, United States System One Full time

Position Title :
Senior Packaging Engineer

Location :
Exton, PA

Work Schedule :
Monday to Friday, 8 AM - 5 PM

Employment Type :
Contract

Overview

A leading global organization focused on Nutrition, Health, and Bioscience, providing innovative solutions for both animal and human nutrition, is seeking experienced Engineers with a background in medical packaging.

Responsibilities

• Innovate and develop new process and tooling concepts for process enhancement, assessing these concepts against key manufacturing performance metrics (KPIs).


• Spearhead the evaluation of scaling options, selection, and execution by managing sub-projects, delivering project updates, and contributing insights for subsequent phases.

• Collaborate with Operations to optimize plant layout, resource allocation, and startup milestones.

• Generate comprehensive documentation to facilitate the scale-up of new or enhanced processes for manufacturing.

• Design, construct, and evaluate semi-automated and automated tooling necessary for process improvement or new product lines.


• Assess potential new product/process proposals and provide strategic recommendations regarding scope and timing to meet production objectives.

• Participate in or lead initiatives related to process implementation through thorough characterization and validation (IQ/OQ/POQ/PQ) activities.

• Create project plans, including cost estimations, operational expenses, project timelines, and resource needs.

• Assist in preparing customer quotes for new or modified products/processes.

• Drive continuous improvement initiatives on projects/processes to enhance productivity, yield, and/or operational costs, alongside root cause analysis (RCA).

• Aid in the preparation of relevant technical sections for grants, patents, and regulatory submissions.


• Oversee the Management of Change (MOC) review process, engage in HAZOP and PSA teams as required, and lead Machinery Safety Assessments (MSA).


• Support the drafting of necessary technical sections for regulatory documents (FDA 510k, IDE, PMA, CE), grants, and patent applications.

Requirements

• Experience in Medical Packaging

• Validation Expertise

CAD Proficiency
Benefits

System One provides eligible employees with a range of health and welfare benefits, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) retirement plan.

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