HVAC CQV Engineer

Hyde Engineering + Consulting; Hyderabad; Sur place; INR 800 000 - 1 200 000; Plein temps

Résumé du poste

An engineering consulting firm located in Telangana, Hyderabad is seeking candidates for HVAC commissioning and qualification in Pharma/Biopharma Facilities. The position requires strong experience in validation procedures and the ability to develop risk assessments, validation plans, and reports. Ideal candidates will have 4-10 years of relevant experience and a BS/MS in Mechanical Engineering. This role emphasizes compliance with cGMP standards and involves independent work as well as team collaboration.

Qualifications

• 4-10 years experience in validation, quality systems, operations, or engineering.
• Experience with GMP validation disciplines and advanced technical knowledge.
• Strong computer skills, including Microsoft Office products.

Responsabilités

• Develop risk assessments and validation plans.
• Conduct commissioning and validation of HVAC and Clean Rooms.
• Prepare system boundaries and facility risk assessments.

Connaissances

Risk assessment

HVAC systems knowledge

Validation protocols

Communication skills

Formation

BS/MS in Mechanical Engineering

Outils

Documentum

Maximo

Description du poste

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.
• Experience working with Documentum or Maximo is 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.