Summary: 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.
Roles & 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.
- 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
Required 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.
