Automation & CSV Engineer

19 hours ago

Hyderabad, Telangana, India Hyde Engineering And Consulting Full time ₹ 15,00,000 - ₹ 28,00,000 per year

Position: Automation & CSV Engineer

Location: Hyderabad

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Responsibilities

  • 5+ years of experience in a Process Automation/Computer System 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.

Education

  • Engineering degree in Chemical, Automation, Biotechnology, EEE.

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