Sr Packaging Engineer

Job Title: Sr Packaging Engineer - 45465

Duties:

Provide technical support to manufacturing in regards to packaging systems and machinery issues.
Prepare packaging validation protocols and perform packaging validation testing to support packaging changes.
Support and qualified packaging material changes.
Create and update packaging specifications (i.e., final package, labels, IFU's, etc.)
Assist in artwork creation and revisions for product packaging.
Works with minimum supervision.

Top 3 things:
1. Experience working with ISO Standard 11607 Packaging for terminally sterilized medical devices standards (Part #1: Requirements for materials, sterile barrier systems and packaging systems & Part #2: Validation requirements for forming, sealing and assembly processes).
2. Experience with different Packaging Process Technologies (FFS, Bar Sealers, Band Sealers, Tray Sealers).
3. Knowledge of Quality Management Systems (Electronic Documents Control Systems)


Education Required: Bachelor's Degree Packaging Science
Years' Experience Required: 3-5 Years of Experience in the related field

Position Basics:

• Knowledge and understanding of ISO 11607 Packaging for terminally sterilized medical devices standards (Part #1: Requirements for materials, sterile barrier systems and packaging systems & Part #2: Validation requirements for forming, sealing and assembly processes).
• Knowledge about Packaging Integrity Testing Methods after Distribution Simulation (Bubble Leak, Dye Leak, Seal Strength, etc.).
• Packaging Stability/Aging Studies
• BS in Packaging, Mechanical, Biomedical, Industrial, Chemical or related Engineering. Packaging Process and Packaging Equipment
• Knowledge about different Packaging Process Technologies (FFS, Bar Sealers, Band Sealers, Tray Sealers).
• Basic Manufacturing Process General Knowledge.
• Machine OQ / PQ Validation General Knowledge. Packaging Materials
• Knowledge about different Material Configurations, applications, and properties (Foil, Tyvek, Films, Nylon, breathable vs. non breathable sterile barrier systems). Quality/Regulations
• Experience using Electronic Document Control Systems (i.e., Agile, etc.)
• Knowledge of Quality Management Systems
• Knowledge and understanding of EU MDR (Medical Device Regulation). Project-Management
• Project Management Skills to lead and execute sustainability, NPD, or packaging improvement projects.
• MS Project, TOPS, CAD Self-Management
• Excellent written and verbal communication skills.
• Multi-task oriented. Will manage multiple projects deliverables at the same time.

Responsibilities may include the following and other duties may be assigned:

• Designs, develops, and tests a wide variety of containers used for the protection, display, and handling of products.
• Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, rough handling, and tampering.
• Designs package exteriors considering such factors as product identification, sales appeal, aesthetic quality, printing and production techniques.
• Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.