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. Solid 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.

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📌 CSV Engineer (India)
🏢 Hyde Engineering And Consulting
📍 India