Validation Engineers ensure that products, systems, and processes meet required specifications and regulatory standards. They develop and execute validation protocols for manufacturing, software, and equipment, particularly in industries such as pharmaceuticals, medical devices, and biotechnology.
Key Responsibilities:
- Validation Planning: Develop validation strategies and protocols to ensure compliance with industry standards and regulatory requirements.
- Testing and Execution: Conduct validation testing, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), documenting results accurately.
- Risk Assessment: Identify and assess potential risks in processes and products, implementing measures to mitigate these risks.
- Documentation: Prepare and maintain comprehensive validation documentation, including reports, procedures, and change controls.
- Collaboration: Work closely with cross-functional teams, including engineering, quality assurance, and regulatory affairs, to ensure seamless validation processes.