Validation Engineer - Pharma and Medical sector

Our client are developing new products and improving/ optimizing existing products and production lines in close dialogue with customers and partners. The company also offers consultants for production support, optimization, validation; project management and quality assurance just to name a few. The customers are often the leading international companies in their specific field Position: As Validation Engineer you play a crucial role in ensuring that products, systems, and processes meet specified requirements and standards before released to the market or implemented. The Validation Engineer ensures that products, equipment, systems, and processes comply with regulatory requirements, industry standards, and company-specific guidelines. This role involves developing and executing validation plans, conducting tests, and documenting results to confirm compliance and functionality. Key Responsibilities: o URS, DQ, FAT, SAT, IQ, OQ, PQ o Develop validation protocols for systems, equipment and/or processes o Execute qualification protocols for installation (IQ), operational performance (OQ) and performance load (PQ) o Execute risk assessments and gap analyses on systems or processes, pFMECA, Hazard o Ensure documentation complies with industry regulations (e.g., FDA, ISO, GMP) o Identify and report any validation deviations and propose corrective actions in collaboration with QA functions You ensure all validation activities align with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 9001, ISO 13485). You collaborate with Quality Assurance an Regulatory Affairs teams to ensure and maintain compliance. You work closely with R&D and manufacturing to integrate validation processes into project development workflows as well as you ongoing analyze validation processes to identify opportunities for improvement.