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
Requirements

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
Job Types: Full-time, Contract

Work Location: In person