Packaging Engineer

About the role

We are seeking an experienced Packaging Engineer to join the Pharmaceutical R&D team. This role focuses on sustaining engineering activities for existing product packaging and packaging processes, supporting quality, regulatory compliance, continuity of supply, and cost-saving initiatives. The engineer will also support new product development by designing, developing, verifying, and qualifying packaging systems and manufacturing processes.

Responsibilities

• Lead and execute packaging engineering projects related to: Quality investigations and CAPA; Regulatory compliance; Supplier Notices of Change (NOC); Cost reduction initiatives; New Product Introductions (NPI)
• Manage multiple packaging projects with moderate complexity while meeting project timelines and milestones
• Develop testing protocols and support Change Control activities
• Collaborate with manufacturing sites, suppliers, quality, regulatory, and cross-functional teams to implement packaging changes
• Evaluate, approve, and qualify new packaging materials, components, and systems
• Create packaging material specifications, engineering drawings, and packaging procedures
• Recommend packaging improvements and cost-saving opportunities through new materials and design modifications
• Troubleshoot packaging-related issues using root cause analysis, statistical methods, DMAIC, and Design of Experiments (DOE)
• Perform financial analysis and project justification for packaging initiatives
• Support manufacturing plants during packaging process qualification and implementation
• Travel to manufacturing facilities and packaging suppliers as needed

Desired experience

Experience with one or more of the following is highly desirable:

• Flexible and rigid packaging films
• HDPE containers
• Foil pouches
• Corrugated packaging design
• Protective packaging
• Thermoforming
• Flow-wrap packaging
• Form/Fill/Seal (FFS)
• Printing technologies
• Packaging validation and qualification

Qualifications

• Bachelor's degree in Packaging Engineering or a related Engineering discipline (Mechanical, Chemical, Biomedical, etc.)
• Minimum 5 years of packaging engineering experience
• Strong knowledge of: Packaging materials and manufacturing processes; Packaging design and development; Statistical analysis; Design of Experiments (DOE); Root Cause Analysis and problem solving; Change Control processes
• Experience managing packaging engineering projects from initiation through implementation
• Strong project management and cross-functional collaboration skills
• Ability to manage multiple priorities with minimal supervision
• Experience applying Lean Manufacturing and Continuous Improvement principles
• Strong written, verbal, and presentation skills
• Experience in the medical device, pharmaceutical, or healthcare industry
• Knowledge of GMP-regulated manufacturing environments
• Experience supporting manufacturing process qualification and packaging validation
• Medical device, particularly Orthopaedic industry experience