Package Validation Engineer

3 days ago

Grand Rapids, United States Insight Global Full time

Why Open: New Headcount

Location: Grand Rapids, MI (4-5 days onsite/week)

Duration: 1-2 year contract


Must-haves

  • Minimum 5 year of experience in packaging
  • Experience in packaging FFS equipment process development and validation IQ/OQ/PQ
  • Experience in manufacturing environment, process or manufacturing engineering
  • Experience with CAPA
  • Established and productive individual contributor with strong team and interpersonal skills
  • Engineering Degree


Plusses

  • Advanced education/ degree
  • Medical device/ FDA regulated industry experience, general understanding of medical device packaging and labeling requirement
  • Project management skills
  • General understanding of Standard requirements; ISO 11607-2, ISO 13485
  • General knowledge of Six sigma methodology and lean manufacturing tools

Day-to-Day

A large medical device company is looking to grow their Packaging and Labeling team by adding a Sr Packaging Engineer to sit onsite in Grand Rapids, MI for a yearlong contract. This person will have a strong career within the packaging space and experience as an individual contributor on a team. The team needs someone to come in and take care of the process validation aspect of packaging and labeling. 50% of their day will be spent working cross functionally with various groups at the manufacturing site. This will entail meetings with manufacturing teams, quality teams, the packaging and labeling engineering team, and the maintenance team. The other 50% of their day will be working on planning on projects and execution of these projects. This entails process development and process validation. This person should be experienced with IQ,OQ,PQ validation model, specifically within packaging FFS equipment. The ideal candidate should be coming from a medical device packaging background who also is experienced within process engineering. This person should have the skillset to be a quick learner while manufacturing and have a background in a manufacturing facility. The ideal candidate will come from a medical device background or a similar FDA regulated industry.

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