Validation Engineer

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)

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

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.

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