Sr Packaging Engineer

Position Summary:

Seeking a highly motivated Sr. Packaging Engineer to support the design, development, validation, and continuous improvement of packaging systems for medical devices. The successful candidate will be responsible for packaging equipment validation, process development, documentation, and ensuring compliance with FDA regulations, ISO standards, and Good Manufacturing Practices (GMP). This role requires close collaboration with Manufacturing, Quality, Regulatory, Automation, and R&D teams to deliver robust packaging solutions for terminally sterilized medical devices.

Key Responsibilities:

• Design, develop, and validate packaging systems for terminally sterilized medical devices in accordance with ISO 11607-1 & ISO 11607-2 standards
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for packaging equipment and manufacturing processes
• Support process validation activities, including process characterization, qualification, and lifecycle management
• Work with high-volume packaging equipment such as Form-Fill-Seal (FFS), Bar Sealers, and Alloyd packaging machines
• Prepare, review, and approve manufacturing instructions, validation protocols, reports, SOPs, and other controlled documentation
• Coordinate with cross-functional teams including Manufacturing, Quality, Regulatory, Automation, and Process Engineering to ensure compliance with product and process requirements
• Develop manufacturing processes, production layouts, and packaging procedures to improve quality, efficiency, and productivity
• Conduct failure investigations, root cause analysis, and implement corrective and preventive actions (CAPA)
• Support statistical process control (SPC), Design of Experiments (DOE), and data analysis using Minitab
• Ensure compliance with FDA 21 CFR Part 820, GMP, ASTM, ISTA, and applicable medical device regulations
• Manage engineering change control activities and support custom equipment validation and Computer System Validation (CSV)
• Lead packaging engineering projects, develop project plans, monitor timelines, and communicate project status to stakeholders
• Provide technical guidance and mentorship to junior engineers when required

Required Qualifications:

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
• Minimum 4 years of relevant experience in packaging engineering, preferably within the medical device industry.
• Hands-on experience with medical device packaging materials and high-volume packaging equipment.
• Strong experience in IQ, OQ, PQ, process validation, and equipment qualification.
• Knowledge of ISO 11607, FDA Quality System Regulations (21 CFR Part 820), and Good Manufacturing Practices (GMP).
• Experience preparing validation protocols, reports, and engineering documentation.
• Strong project management and cross-functional collaboration skills
• Excellent analytical, problem-solving, and communication skills

Preferred Qualifications:

• Experience with ASTM and ISTA packaging standards
• Knowledge of DOE (Design of Experiments) and proficiency with Minitab
• Experience with Computer System Validation (CSV)
• SOP development and document control experience.
• Medical device change control and custom equipment validation experience.
• Familiarity with Statistical Process Control (SPC) and manufacturing process optimization.