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Packaging Subject Matter Expert
4 months ago
Location: Franklin Lakes, NJ 07417 (Hybrid)
Position Type: Contract
Duration: 12 Months
The individual in this position will be a Packaging subject matter expert (SME) to provide support for design, development, verification and validation of sterile medical device packaging (e.g. sterile barrier systems) under the Enterprise Cost-To-Win (eCTW) Program for the Client Specimen Management business.
Education:
- Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.
Qualifications:
- Required Med Device or Pharma experience
- Design control, Design Validation and Verification
- Working knowledge of packaging industry standards and regulations, including:
o Packaging Engineering Design (medical device sterile packaging design)
o Packaging materials (flexible and rigid) & sterilization processes
o Packaging Testing methods
o Labeling Testing methods (PTS)
o High volume regulated manufacturing
o ISO-11607/ASTM D4169
o ISO 13485/21 CFR Part 820