Validation Engineer

3 weeks ago


Raynham, United States Insight Global Full time

Must Haves:

  • Bachelor's Degree in Engineering, Science, or related field
  • 1-5 years of experience with writing and executing validation documentation
  • Knowledge of statistical data analysis tools (Minitab)

Pluses:

  • Experience in manufacturing: metal casting processes, CNC machining processes, metal finishing processes, Gage R&R CNC equipment, plastic or wax injection, laser processing or production automation
  • Experience in a Medical Device work environment.
  • Experience working in both an FDA and European regulatory environment in manufacturing/operations.

Job Description:

Insight Global is hiring for a Validation Engineer in Massachusetts to support their client. They will be supporting a large-scale foundry capacity expansion project within the Raynham, MA, manufacturing facility. This position is based on-site as the engineer will be required to interface with manufacturing equipment, medical device products, and cross-functional partners.

Responsibilities:

  • Developing, writing, reviewing, maintaining and revising manufacturing documentation, i.e. Process Work Instructions, Manufacturing Specifications, Inspection Procedures to support product Manufacturing
  • Supporting the development and execution of manufacturing equipment qualifications (URS/FAT/SAT/IQ)
  • Supporting the development and execution of process validations (OQ/PQ/PV)
  • Developing, writing, and reviewing various validation deliverables, i.e. CSV-E, Engineering Studies, etc.
  • Assessing, developing, writing, executing, and reviewing Test Method Validations (TMVs)
  • Partnering with cross functional partners to ensure sound validation strategy and smooth transitions to production go-live
  • Ensuring adequate documentation where necessary within the Quality System

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