Senior Package Development Engineer (orthopedics)

Johnson & Johnson Johnson & Johnson · Pharma · West Chester, PA +2

Senior Package Development Engineer for Orthopedics (Trauma) at Johnson & Johnson (DePuy Synthes). Role involves participating in audits, providing technical expertise for risk assessments and compliance assurance, ensuring robust and compliant packaging solutions, leading troubleshooting for packaging issues, and maintaining knowledge of industry and regulatory trends. Requires a Bachelor's degree in engineering or equivalent, 4-6 years of experience in packaging, experience in a regulated environment, and project management skills.

What you'd actually do

  1. Participates in internal and external Audits and provides technical expertise for risk assessments and compliance assurance programs. Ownership of submissions of Packaging Design Documentation to notified bodies
  2. Assures delivery of robust, cost effective, fully compliant packaging solutions that meet current and evolving customer's needs.
  3. Has full technical responsibility for interpreting, organizing, executing and coordinating assignments.
  4. Leads troubleshooting in the resolution of packaging related issues in manufacturing and the field. Develops recommendations on general packaging guidelines and standards for processes and functional requirements.
  5. Oversees issue management with technical responsibility to ensure problems are solved in a compliant and effective manner and ensure our organization reaches high levels of efficiency.

Skills

Required

  • Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience
  • 4 – 6 years related experience
  • Experience in the packaging industry
  • Experience in packaging qualification or laboratory testing
  • Experience in a regulated environment
  • Demonstrated record of successful project management.
  • Application and interpretation of process DOE’s (mini-tab preferred), GR&R, IQ/OQ/PQ, Fishbone, etc. is required
  • Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services

Nice to have

  • Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred
  • Analytical Reasoning
  • Brand Research
  • Controls Compliance
  • Detail-Oriented
  • EHS Compliance
  • Good Manufacturing Practices (GMP)
  • Lean Supply Chain Management
  • Package and Labeling Regulations
  • Product Packaging Design
  • Proof Reading Software
  • Quality Assurance (QA)
  • Safety-Oriented
  • Science, Technology, Engineering, and Math (STEM) Application
  • Supervision
  • Supply Planning
  • Technologically Savvy

What the JD emphasized

  • regulated environment
  • packaging qualification
  • laboratory testing
  • ISO13485
  • ISO11607
  • ISTA
  • ASTM
  • process DOE’s
  • GR&R
  • IQ/OQ/PQ
  • Fishbone