What are the responsibilities and job description for the Validation Engineer (Medical devices) position at INTELLECTT INC?
Responsibilities :
- Commissioning & Validation :
- Write and execute commissioning, qualification, and validation protocols for facilities, utilities, equipment, and computerized systems.
- Write final reports detailing the results of validation activities.
- Resolve protocol discrepancies and deviations by implementing corrective actions.
- Review vendor-generated validation protocol packages to ensure compliance with standards.
- Documentation & Reporting :
- Generate complex protocols using a risk-based approach that adheres to current regulatory requirements and industry practices.
- Maintain detailed and accurate documentation throughout the validation process.
- Collaboration & Communication :
- Collaborate with cross-functional teams to ensure the validation of all relevant systems and equipment.
- Maintain excellent communication with both internal stakeholders and external vendors to ensure smooth execution of validation tasks.
- Regulatory Compliance :
- Ensure that all validation activities align with FDA, cGMP, and industry standards.
- Support audits and inspections, providing validation documentation as needed.
Skills and Qualifications :
