Validation / Manufacturing Engineer

Must have skills*

• 3-5 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.
• Experience with CMM (Coordinate Measuring Machine) equipment.
• Experience in project management.
• Experience with machining processes, metal finishing processes, laser processing or production automation.
• Knowledge of statistical data analysis and associated tools (e.g. Minitab).

Key responsibilities*

• Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
• Participates in projects including developing and executing to the plan, schedule and meeting the goals/objectives.
• Leading/executing Installation Qualification, Process Validation experience
• Supports new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
• Develops and implements manufacturing and inspection procedures.
• Provides technical support in the development and implementation of advanced manufacturing technologies including fixtures, tools and gages for production.
• Participates in and understands compliance related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
• Supports and operates in a proactive safety environment