Job Description

Validation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise.
Location: SouthEast, United States (Travel Required)

Scope Includes:

• Validation of new molding and assembly units
• Qualification of ISO7 clean rooms
• Integration of metrology instruments and handling systems
• Execution of IQ/OQ/PQ protocols, FAT/SAT, and traceability documentation
• Collaboration on a comprehensive Validation Master Plan

Qualifications

• Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial)
• Location: SouthEast, United States (Travel Required)

Technical Skills

• IQ/OQ/PQ protocol development and execution
• FAT/SAT testing and documentation
• Validation Master Plan (VMP) creation
• MES/SCADA system qualification
• Injection molding and automated assembly validation
• Metrology equipment calibration and Gage R&R
• Traceability Matrix development
• Experience with KNEAT software (highly desirable)

Regulatory Knowledge

• FDA 21 CFR Part 820
• EU MDR 2017/745
• ISO 13485 & ISO 14971
• GMP compliance

Certifications

• ISO 13485 Quality Management
• ISO 14971 Risk Management
• GMP Training
• Six Sigma (Green or Black Belt)

Soft Skills

• Strong documentation and report writing
• Cross-functional collaboration
• Ability to train personnel
• Analytical thinking and problem-solving

Additional Information

All your information will be kept confidential according to EEO guidelines.