About the job
Our client is at the forefront of product innovation, focusing on the development and optimization of advanced products and production lines through close collaboration with customers and partners. They also provide expert consulting services for production support, optimization, validation, project management, and quality assurance, serving leading international companies within their sectors.
Position Overview:
As a Validation Engineer, you will be instrumental in verifying that products, systems, and processes adhere to requisite standards and regulations prior to market launch or implementation. You will ensure that all products, equipment, systems, and processes align with industry regulations, including FDA and ISO standards. This position entails crafting and executing validation plans, performing tests, and documenting outcomes to validate compliance and operational effectiveness.
Key Responsibilities:
- Develop User Requirement Specifications (URS), Design Qualifications (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Create validation protocols for systems, equipment, and processes.
- Conduct qualification tests and execute risk assessments and gap analyses on systems and processes, including pFMECA and hazard analyses.
- Ensure that documentation adheres to industry standards such as FDA, ISO, and GMP.
- Identify validation deviations and collaborate with Quality Assurance teams to propose corrective actions.
You will ensure that all validation efforts meet applicable regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 9001, ISO 13485) and work in partnership with Quality Assurance and Regulatory Affairs to maintain compliance. Additionally, you will collaborate closely with R&D and manufacturing to integrate validation processes into project workflows and continuously analyze validation processes for improvement opportunities.