CSV Engineer

Responsibilities 5+ years of experience in a Computer Systems Validation role in a Pharma, biopharmaceutical manufacturing environment. Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation Support to change controls, investigations, deviations, and CAPAs Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results Working closely with the systems integrators, automation leads & process leads Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation Knowledge of E2500,V Model concepts along with GAMP5, S88,S95 Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus Ability to travel up to 50% or more within and outside India Knowledge of Delta-V DCS systems, Rockwell qualification Knowledge of PI Historian. Large scale project experience. Valid Passport with no restrictions to travel any geography Education Engineering degree in Chemical, Automation, Biotechnology.