C&Q Engineer - HVAC Jobs in Hyderabad - Hyde Engineering Consulting

CQ Engineer - HVAC

Hyde Engineering Consulting

0 to 3 Years

Not disclosed

Expired

Posted: 25 Jun 20

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