Packaging Engineer

17 hours ago

Andhra Pradesh, India Horizontal Talent Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role: Packaging Engineer

Experience: 5 Years

Notice Period: Immediate

Location: Hyderabad

Nice To Have

1. Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO

(Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.

2. Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO Part 2: Validation requirements for forming, sealing and assembly processes).

These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices

3. Process Validation and Computer software validation knowledge.

4. Creo / Solid works experience

5. Computer literacy in MS Word, Excel, PowerPoint.

6. Also, supplier interaction, manufacturing transfer and qualification (PPAP) etc. are must to have skills.

  • Design Verification (Protocol and Report out) procedure
  • Good knowledge on Process Validation (IQ/OQ/PQ)
  • Performance Testing
  • Distribution testing
  • Understands Packaging Materials and sterilization
  • Good understanding of packaging Standards
  • Experience in defining worst case scenarios and sample size justification
  • Well verse with Good documentation Practices part of Audit team.

Bachelors in Packaging or related engineering field (e.g. Mechanical or Materials) detail-oriented Packaging Development effectively communicating packaging development

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