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.