HVAC CQV Engineer

Immediate Joiners Preferred!!!!! 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