Validation Engineer
3 weeks ago
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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