CQV Engineer — EMS

1 day ago

Hyderabad, Telangana, India Hyde Engineering + Consulting Full time US$ 80,000 - US$ 1,20,000 per year

Position: CQV Engineer — EMS and BMS Room
Location: India
This position shall perform commissioning and qualification of EMS and BMS Systems in Pharma/Biopharma Facilities.

Responsibilities

  • Develop URS, risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
  • Develop and execute Commissioning and validation of EMS and BMS Systems
  • Preparation of System Boundaries, SLIA, CLIA, QRA, Design Qualification Report, Traceability Matrix ,Facility Risk Assessments
  • Develop Protocols and Execute test plans for BMS and EMS Systems.
  • Perform IO Testing ,Control Logics Verification of DDC/PLC and SCADA /Software Testing.
  • Software Verification – SCADA GUI, Reports, Control Access and Security Policies, Power Failure and Communication Failure, Audit Trail Verification, Alarms and Interlocks, Data Backup and Restoration, Control Logics.
  • Perform walkdowns with wiring diagram, P&ID's and System Architecture ,Air Flow drawings.
  • Knowledge on the system architectures of BMS and EMS .
  • Knowledge on Control logics for T RH, DP, Air flow and Fire Damper ,Smoke and other interlocks in BMS System.
  • Good knowledge of field instruments and devices and their functionality like Temperature and RH transmitters, Level transmitters, Flow meters, Velocity Sensors, control valves, Differential pressure transmitters, Smoke Sensors etc. Verify the instruments calibration reports.
  • Hands on experience in commissioning of other ELV Systems such as Door Interlocks, Access controls ,Fire Alarm Systems etc.
  • Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
  • Investigate deviations, write investigation reports and propose corrective and preventive actions and create summary reports.
  • Promote cGMP and regulatory compliance into assigned projects.
  • Knowledge of GAMP ,EU Annexure 11 and US FDA 21 CFR 11 Guidelines .
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Qualifications & Other Requirements

  • BS/MS in Electronics and Communications Engineering.
  • 4-10 years in validation, engineering ,quality systems, operations, or any combination thereof.
  • Experience in multiple GMP validation disciplines with advanced technical knowledge.
  • Validation experience using , traditional, risk based, Hybrid approach.
  • Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ,OQ,& PQ Protocols, etc.) guidelines, international regulatory requirements and standards and other in.
  • Experience working with Documentum or Maximo a plus.
  • Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
  • Experience with investigations into deviations and determination of product impact potential, root cause and corrective actions.
  • Strong verbal and written communication skills; excellent organizational and time utilization skills
  • Ability to work independently and within project teams.
  • Industry experience related to cGMP drug manufacturing, validation.
  • Strong computer knowledge including Microsoft Office products
  • Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel

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