- Prepare packaging validation protocols and reports to support packaging changes.
- Perform packaging validation testing to support changes.
- Lead material qualifications for packaging changes such as resin material changes.
- Create and update packaging specifications for manufacturing.
- Assist in artwork creation and revisions for product packaging.
- Operate various testing apparatus in qualifying packaging changes.
- Create sterilization pallet patterns as well as non-sterile pallet patterns for manufacturing locations.
- Ensure on time delivery to Project Engineering and R&D schedules and plans.
- Prepares monthly progress reports on projects.
Must-Have :
- Bachelors degree required Minimum of 7 years of relevant experience, or Packaging Master degree with a minimum of 2 years relevant experience
- Prior experience on EUMDR packaging remediation
Nice to Have:
Specialized Knowledge or Skills:
- Core Knowledge In:-Packaging Engineering
- -Lab standards
- -Packaging materials & sterilization processes
- -ISO-11607
- -Design Control
- -Managed or lead root cause analysis / CAPA
- -6 Sigma and Lean Principals
- -Project Management Principals
- Developing Knowledge In: -Supply Chain
Desired Qualifications:
- Ability to prepare written policies, procedures, proposal, and reports.
- Effective communication skills with superiors (department managers, senior management, steering committee members, cross functional vice presidents), peers, and subordinates.
- Ability to plan and document projects effectively. Ability to manage multiple ongoing projects by way of good organizational skills.