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Packaging Subject Matter Expert

4 months ago


Franklin Lakes, United States Indotronix Avani Group Full time

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