Packaging Engineer

Katalyst CRO; Dallas (TX); Presencial; USD 95.000 - 130.000; Jornada completa

Descripción de la vacante

Katalyst CRO in the United States seeks an experienced Packaging Engineer to join the Pharmaceutical R&D team. The role covers sustaining engineering for existing packaging, quality support, regulatory compliance, and cost-saving initiatives.

You will design, develop, verify, and qualify packaging systems and processes, lead projects across sites and suppliers, perform testing and DOE analyses, and support GMP-regulated manufacturing.

Formación

• Bachelor's degree in Packaging Engineering or related discipline.
• Minimum 5 years of packaging engineering experience.
• Strong knowledge of packaging materials and manufacturing processes.
• Experience with GMP-regulated environments.
• Experience in medical device/pharma sector.

Responsabilidades

• Lead and manage packaging projects with moderate complexity.
• Develop testing protocols and support Change Control.
• Collaborate with manufacturing sites, suppliers, quality, and regulatory teams.
• Evaluate and qualify new packaging materials and systems.
• Create packaging specifications, drawings, and procedures.
• Troubleshoot packaging issues using RCA, DMAIC, and DOE.
• Travel to facilities and suppliers as needed.

Conocimientos

Packaging engineering

Quality investigations

DOE

CAPA

Regulatory compliance

Project management

Cross-functional collaboration

GMP knowledge

Change Control

Lean Manufacturing

Educación

Bachelor's degree in Packaging Engineering or related engineering discipline

Descripción del empleo

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.

• 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


• Protective packaging


• Thermoforming


• Flow-wrap packaging


• Form/Fill/Seal (FFS)


• Printing technologies


• Packaging validation and qualification

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.