Hyde Engineering Consulting jobs - CQ Engineer - HVAC

CQ Engineer - HVAC

Hyde Engineering Consulting
experience 0 to 3 Years
salary Salary not disclosed
qualification
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Posted: 3 Years ago
Views: 0
Applications: 1
Openings: 1

Job Description

This position shall perform commissioning and qualification of HVAC, Clean Rooms, EMS and BMS Systems in Pharma/Biopharma Facilities.

Responsibilities
  • Develop 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 Clean Rooms, HVAC systems, EMS and BMS Systems
  • Preparation of System Boundaries, SLIA, CLIA, QRA, Facility Risk Assessments
  • Develop Protocols and Conduct Tests like HEPA Filter Integrity Testing, Air velocity, Recovery Testing, ACPH, Airflow pattern study, DP monitoring, Non-viable particle counting, Viable Particle Counting, etc.
  • Develop Protocols and Execute the same for BMS and EMS Systems.
  • 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 create summary reports.
  • Promote cGMP and regulatory compliance into assigned projects.
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Qualifications & Other Requirements
  • BS/MS in Mechanical Engineering.
  • 4-10 years in validation, quality systems, operations, engineering 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 manufacturing 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, and chemical process design
  • 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


Job Particulars

Who can applyFreshers and Experienced (0 to 3 Years )
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id379845
StateTelangana
Country India

About Company

Hyde Engineering + Consulting
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