Engineer

Job Title

Validation / Manufacturing Engineer

Must have skills*

• 2-5 years of experience in manufacturing and/or process engineering.

• Development of specifications and user requirements for new equipment that supports manufacturing operations

• Planning, development, and execution of equipment/process qualifications as it relates to CNC machining, manufacturing, inspection, and production readiness

• Support development of and author Process Validation/Verification/ Qualification documents, Work Instructions, Manufacturing Specifications, and Standard Operation Procedures, etc.

• Perform statistical analysis of data to determine process capability

• Assess, review, and support the development of product inspection Test Methods and Test Method Validations (TMV's)

• Support cross functional teams working on equipment/facility commissioning and qualification

• Takes ownership of validation/verification deliverables throughout execution of Project

• Ensures technical deliverables are completed to schedule

• May require international travel (up to 10%)

Good to have skills*

• Experience working in a regulated industry, such as Medical Device, Pharma or Biotech.