Packaging Engineer

Katalyst-Healthcares-; Dallas (TX); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking an experienced Packaging Engineer to join our Pharmaceutical R&D team. This role focuses on sustaining engineering for existing product packaging, supporting quality, regulatory compliance, continuity of supply, and cost-saving initiatives.

You will design, develop, verify, and qualify packaging systems and manufacturing processes, lead projects, collaborate with manufacturing sites and suppliers, and travel as needed.

Qualifikationen

• Bachelor's degree in Packaging Engineering or related field.
• Minimum 5 years packaging engineering experience.
• Knowledge of packaging materials, design, and processes.
• Experience with GMP environments and change control.
• Experience in medical device/pharma manufacturing is preferred.

Aufgaben

• Lead packaging projects focusing on quality investigations, regulatory compliance, and cost reductions.
• Develop testing protocols and support Change Control activities.
• Collaborate with manufacturing sites, suppliers, quality, regulatory, and cross-functional teams.
• Evaluate and qualify new packaging materials and systems.
• Create packaging specs, drawings, and procedures.
• Assist in packaging validation and process qualification.
• Travel to facilities and suppliers as needed.

Kenntnisse

Project Mgmt

Cross-functional

DOE

RCA

Statistical analysis

Lean manufacturing

Communication skills

GMP compliance

Packaging design

Pharma/medical device experience

Ausbildung

Bachelor's degree in Packaging Engineering

Jobbeschreibung

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.