Packaging Engineer

Job Title: Packaging Engineer

Location: Minneapolis, MN

Duration: Long Term

We are seeking an experienced Packaging Engineer to support the design, development, validation, and optimization of packaging systems for pharmaceutical and medical device products. This role will focus on packaging process improvement, equipment qualification, regulatory compliance, and ensuring product integrity throughout the manufacturing and distribution lifecycle. The ideal candidate will have experience with pharmaceutical or medical device packaging, packaging validation, GMP compliance, and cross‑functional collaboration.

• Design, develop, and optimize packaging processes for pharmaceutical or medical device products.
• Support packaging equipment qualification, validation, and commissioning activities.
• Develop and maintain packaging specifications, SOPs, protocols, and technical documentation.
• Ensure packaging systems comply with GMP, FDA, ISO, and internal quality standards.
• Identify opportunities to improve packaging efficiency, reduce waste, and optimize production performance.
• Collaborate with Manufacturing, Production, Quality Assurance, Engineering, Supply Chain, and Validation teams to support new product launches and ongoing manufacturing operations.
• Troubleshoot packaging equipment and process‑related issues while implementing effective corrective actions.
• Support packaging validation, transportation studies, and product stability initiatives.
• Participate in root cause investigations, CAPA implementation, and continuous improvement projects.
• Ensure packaging materials and processes meet product protection, regulatory, and customer requirements.

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Packaging Engineering, Manufacturing Engineering, or a related engineering discipline.
• Experience in pharmaceutical, biotechnology, or medical device packaging operations.
• Strong knowledge of packaging validation, equipment qualification, and packaging quality standards.
• Familiarity with GMP, FDA regulations, ISO standards, and packaging compliance requirements.
• Hands‑on experience with automated packaging equipment and packaging line operations.
• Understanding of packaging materials, labeling systems, serialization, and product protection requirements.
• Experience developing packaging documentation, specifications, SOPs, and validation protocols.
• Strong analytical, troubleshooting, problem‑solving, and process improvement skills.
• Excellent communication skills with the ability to collaborate across cross‑functional teams.
• Experience supporting Lean Manufacturing, Six Sigma, or continuous improvement initiatives is preferred.
• Knowledge of transportation validation, package testing, and stability studies is an added advantage.