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

- Solid computer knowledge including Microsoft Office products

- Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel

📌 HVAC CQV Engineer (Hyderabad)
🏢 Hyde Engineering + Consulting
📍 Hyderabad