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Skills
Biomedicineunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cost Controlunmatched
Cross-Functionalunmatched
Engineeringunmatched
Engineering Drawingunmatched
Engineering Managementunmatched
Experiment Designunmatched
Financial Analysisunmatched
GMP (Good Manufacturing Practices)unmatched
Healthcareunmatched
Identify Issuesunmatched
Lean Manufacturingunmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Materials Engineeringunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Multitaskingunmatched
Network Operations Centerunmatched
Orthopedicsunmatched
Presentation/Verbal Skillsunmatched
Printingunmatched
Problem Solving Skillsunmatched
Product Designunmatched
Product Developmentunmatched
Product Packagingunmatched
Product Supportunmatched
Product/Service Launchunmatched
Project/Program Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Root Cause Analysisunmatched
Six Sigma DMAICunmatched
Statisticsunmatched
Team Playerunmatched
Test Plan/Scheduleunmatched
Time Managementunmatched
United States Department of Energy (DOE)unmatched
Willing to Travelunmatched
Writing Skillsunmatched
Description
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.