Senior Packaging Engineer, Pharma R&D & NPI

Katalyst-Healthcares-; Huntsville (AL); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC seeks an experienced Packaging Engineer to join the Pharmaceutical R&D team in Huntsville, AL. The role focuses on sustaining packaging processes and supporting new product development through design, qualification and cost-saving initiatives.

You will lead projects, collaborate with manufacturing sites and suppliers, and apply GMP-aware processes to ensure quality and regulatory compliance across packaging systems.

Qualifications

• Bachelor's degree in Packaging Engineering or related Engineering discipline (Mechanical, Chemical, Biomedical, etc.).
• Minimum 5 years of packaging engineering experience.
• Strong knowledge of packaging materials and manufacturing processes, design and development, statistical analysis, DOE, RCA and Change Control.

Responsibilities

• Lead and execute packaging engineering projects related to quality investigations, regulatory compliance, cost reduction, NPI and NOC.
• Manage multiple packaging projects with moderate complexity and timelines.
• 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 and systems.
• Create packaging material specifications, engineering drawings and packaging procedures.
• Identify cost-saving opportunities through new materials and design modifications.
• Troubleshoot packaging issues using root cause analysis, DMAIC and DOE.
• Perform financial analysis and project justification for packaging initiatives.

Skills

Packaging engineering

Project management

Statistical analysis

DOE

Root Cause Analysis

Lean manufacturing

Education

Bachelor's degree in Packaging Engineering

Job 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.