Engineer II, Validation

We are currently hiring a Validation Engineer to support validation activities for clinical diagnostic reagent manufacturing in a cGMP, FDA-regulated, and ISO 13485 environment. Key responsibilities include developing and executing validation protocols and collaborating with cross-functional teams. Ideal candidates have relevant validation experience in regulated environments.

Skills

• fmea
• risk analysis
• deviation investigation
• validation protocol development
• statistical analysis
• corrective action implementation
• cgmp compliance
• validation documentation
• validation data analysis
• calibration coordination
• iso 13485
• metrology
• fda regulations
• computer system validation
• cross-functional collaboration
• process control
• root cause analysis
• quality management systems
• automation systems
• capa