Senior Packaging Engineer

JobDiva, Inc.; North Haven (CT); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking an engineer to support and improve packaging operations for medical device manufacturing, leading process development, equipment qualification, and validation activities (IQ/OQ/PQ).

You will collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve production issues, implement continuous improvement, and ensure compliance with FDA quality systems. Strong problem solving and cross-functional leadership required.

Qualifikationen

• Bachelor’s degree in packaging/engineering and related field is required.
• Experience in regulated manufacturing environments preferred.
• Knowledge of packaging validation, quality systems, and regulatory requirements.

Aufgaben

• Support and improve packaging operations for medical device manufacturing.
• Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering to resolve production issues and drive continuous improvement; ensure FDA and quality system compliance.

Kenntnisse

Lean Manufacturing

Six Sigma

Root Cause Analysis

CAPA

Cross-Functional Collaboration

Project Leadership

Technical Communication

Ausbildung

Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering

Jobbeschreibung

Responsibilities:

• Responsible for supporting and improving packaging operations for medical device manufacturing. Lead packaging process development, equipment qualification, and validation activities (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA and quality system requirements.
• Perform root cause investigations, develop CAPA solutions, maintain technical documentation, support packaging equipment and process validation, and drive operational excellence using Lean Manufacturing and Six Sigma methodologies. Strong problem-solving, project leadership, technical communication, and cross-functional collaboration skills are required.

Requirements:

• Bachelor's Degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or related Engineering discipline.
• Engineering experience (or equivalent advanced degree and relevant experience).
• Experience in Medical Device, Healthcare, Pharmaceutical, or other regulated manufacturing environments preferred.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.