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.
