What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Job Summary
- Validation Engineer Manufacturing Operations responsible for overseeing complex production processes for surgical devices, leading validation activities, troubleshooting electro-mechanical systems, and ensuring manufacturing efficiency, compliance, and quality standards.
- Oversee and optimize complex production processes for surgical devices to meet efficiency and quality standards.
- Serve as the primary technical expert for electro-mechanical equipment issues, perform root cause analysis, and implement corrective actions to reduce downtime.
- Lead development and execution of validation strategies including IQ/OQ/PQ for new and existing equipment.
- Apply Lean principles to identify waste reduction and improve process stability.
- Lead NCMR and CAPA investigations to maintain quality system compliance.
- Support adaptation of machine/equipment design to production and factory conditions.
- Troubleshoot automated systems including robotics, motion control, and machine vision.
- Perform statistical analysis such as process capability, process control, DOE, and inspection design.
- Ensure component qualification using PPAP methodologies.
- Bachelor's degree in Electrical Engineering, Controls, Automation, Mechatronics, or related field.
- 10 years of manufacturing engineering experience (or 8 years with a Master's degree).
- Strong expertise in medical device process validation (IQ/OQ/PQ), statistical tools such as Minitab, and high-volume manufacturing assembly.