Validation & CSV Consultant

The position of Validation & CSV Consultant requires a highly experienced MES Validation Engineer to support the validation and implementation of MES tools such as Rockwell FTPS, Honeywell MES, and related systems within regulated environments. With over 10 years of relevant experience, you will play a crucial role in ensuring compliance with FDA, GMP, GAMP, and other industry regulations. Your key responsibilities will include developing and executing validation protocols (IQ/OQ/PQ) for MES platforms, collaborating with cross-functional teams to drive successful validation outcomes, conducting risk assessments, maintaining accurate documentation, troubleshooting issues, providing user training and support, and managing data migration and qualification activities. You will also be involved in continuous improvement efforts to enhance validation methodologies. To qualify for this role, you should possess a Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field, along with 5-10 years of hands-on validation experience in pharmaceutical, biotech, or manufacturing sectors. Strong expertise in Rockwell FTPS, PharmaSuite, and/or Honeywell MES, as well as knowledge of OT validation, data migration, and system integrations, are essential. Familiarity with regulatory compliance standards such as FDA 21 CFR Part 11, Annex 11, and GAMP 5 is required, along with proficiency in Microsoft Office Suite and validation tools, preferably Kneat. Preferred skills for this role include experience with MES-LIMS and MES-SAP interface validation, proficiency in using Kneat Validation Software, and a background in OT system validation and commissioning. Strong analytical, communication, and cross-functional collaboration skills will be critical for success in this position. If you are looking to join a dynamic team and contribute to the validation and CSV activities in the pharmaceutical industry, this role might be the perfect fit for you. The hiring process will involve screening by HR, followed by two technical rounds, and a final HR round. Join us in our mission to drive excellence in validation processes and ensure compliance with industry standards.,