Sr Packaging Engineer

Title: Sr Packaging Engineer

Contract duration 08 months

Sr. Packaging Engineer

Overview

Sr. Packaging Engineer supporting the CST business unit. This contractor will lead and support packaging-related work tied to manufacturing transfer, process validation, design verification in a regulated medical device environment.

Day-to-Day Responsibilities

• Collaborate with R&D, Manufacturing, Quality, and Supply Chain teams.
• Develop and execute packaging test protocols and reports.
• Support validation and verification documentation.
• Evaluate packaging changes and associated technical rationale.
• Ensure compliance with FDA and EU MDR expectations.

Top 3 Technical Skills Required

Must Have

Technical Skills

1. Change Control of Medical Devices
2. Equipment Commissioning / Qualification
3. Process Validation
4. Computer System Validation (CSV)
5. Manufacturing, Packaging and Laboratory Equipment
6. Technical experience (Troubleshooting) or similar background
7. Quality / Process Control / Assurance of Medical Devices

Packaging & Regulatory Experience

1. Design and development of a packaging system for terminally sterilized medical devices per requirements established by:
2. • ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems)
   • Corresponding packaging ASTM standards
   • ISTA (International Safe Transit Association) standards
3. Validation of processes for packaging medical devices that are terminally sterilized per:
   Processes include:
4. • ISO 11607-2 (Part 2: Validation requirements for forming, sealing and assembly processes)
5. • Forming
   • Sealing
   • Assembly of preformed sterile barrier systems
   • Sterile barrier systems
   • Packaging systems
6. Strong working knowledge of:
7. • FDA Medical Devices Part 820 Quality System (QS) Regulation
   • Medical Device Good Manufacturing Practices (GMP)

Validation Experience

1. Experience in Equipment IQ
2. Process Validation Lifecycle:
3. • Process Characterization
   • OQ (Operational Qualification)
   • PQ (Performance Qualification)

Experience Requirement

• 5 years of experience with a BS in Packaging or related Engineering field OR
• 3 years of experience with an MS

Testing Experience

• Sterile Barrier Testing

Nice to Have

• 3D Modeling
• Applied Minitab Analysis
• Cost Savings Analysis
• Packaging Engineering experience in regulated medical device or other regulated industries

Additional Requirements

1. Manufacturing Transfer experience
2. Process Validation experience
3. Design Verification experience
4. Working knowledge of FDA and EU MDR requirements, including:
5. • Technical documentation
   • Justification support

Education Required

Bachelor’s degree in:

• Packaging Engineering
• Mechanical Engineering
• Biomedical Engineering
• Related Technical Field

Years of Experience Required

Typically 5 to 8 years of relevant Packaging Engineering experience, with strong preference for experience in regulated medical device environments.

Additional Responsibilities

Responsibilities may include the following and other duties as assigned:

• Design, develop, and test a wide variety of containers used for the protection, display, and handling of products.
• Determine packaging specifications according to:
• • Product requirements
  • Cost limitations
  • Legal requirements
  • Type of protection required
• Consider protection against:
• • Moisture
  • Corrosive chemicals
  • Temperature variations
  • Light
  • Heat
  • Rough handling
  • Tampering
• Design package exteriors considering:
• • Product identification
  • Sales appeal
  • Aesthetic quality
  • Printing techniques
  • Production techniques
• Manage and/or coordinate GMP documentation.
• Support prototype line development in manufacturing facilities/plants.

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