Packaging Engineer

Katalyst CRO; Round Lake (IL); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Katalyst CRO is seeking an experienced Packaging Engineer to join the Pharmaceutical R&D team in Round Lake, Illinois. The role centers on sustaining engineering for existing packaging and processes, ensuring quality, regulatory compliance, continuity of supply, and cost savings while supporting new product development.

The successful candidate will design, develop, verify, and qualify packaging systems and manufacturing processes, lead projects across CAPA, NOC, NPI, and supplier changes, and

Qualifications

• Bachelor's degree in Packaging Engineering or a related field.
• Strong knowledge of packaging materials and manufacturing processes.
• Experience with statistical analysis and DOE methods.
• Experience in GMP-regulated environments and packaging validation.

Responsabilités

• Lead and execute packaging projects including quality investigations, CAPA, regulatory compliance, NOC handling, cost reductions and NPI.
• Manage multiple projects with timelines and milestones.
• Develop testing protocols and support Change Control activities.
• Collaborate with manufacturing, suppliers, quality, regulatory and cross‑functional teams.
• Evaluate and qualify new packaging materials, components and systems.

Connaissances

Packaging design

Statistical analysis

Project management

Cross-functional collaboration

Lean/CI

Formation

Bachelor's degree in Packaging Engineering or related

Description du poste

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.