Sr. Packaging Engineer

Key Requirements:

• Bachelor's degree in Packaging, Mechanical, Manufacturing Engineering, or related field.
• 4+ years of relevant packaging engineering experience, preferably in medical devices.
• Strong experience with medical packaging materials and packaging equipment .
• Experience with high-volume packaging equipment such as FFS, bar sealers, and Alloyd .
• Strong knowledge of IQ, OQ, PQ, PDR, and process validation .
• Knowledge of ISO 11607, FDA 21 CFR Part 820, GMP, ASTM, and ISTA standards.
• Experience with packaging equipment validation, DOE/Minitab, SOPs, change control, and documentation.
• Strong project management and cross-functional communication skills.

Key Responsibilities:

• Design, develop, and validate packaging systems for medical devices.
• Lead packaging equipment and process validation activities.
• Prepare and review protocols, reports, work instructions, and other documentation.
• Identify and resolve manufacturing and packaging process issues.
• Ensure processes comply with FDA and applicable industry standards.
• Manage project deliverables, timelines, and cross-functional activities.