Hvac And Utility Validation Engineer

Job Description MDI Equipment & Utility Validation Professional

Position

MDI Equipment & Utility Validation Engineer / Senior Validation Engineer

Location

Indore, Madhya Pradesh (On-site)

Employment Type

Full-Time / Contract (Based on Project Requirement)

Industry

Pharmaceutical | Life Sciences

About the Opportunity

Forvis Mazars is hiring experienced professionals for a leading pharmaceutical client engaged in Metered Dose Inhaler (MDI) manufacturing. We are looking for validation professionals with strong expertise in pharmaceutical equipment qualification, utility validation, HVAC systems, and GMP-compliant validation practices.

This role offers an opportunity to work on state-of-the-art pharmaceutical manufacturing facilities while ensuring compliance with global regulatory standards.

Key Responsibilities

Equipment Qualification

• Execute Equipment Qualification activities including IQ, OQ, PQ, and requalification.
• Prepare, review, and execute Validation Protocols and Reports.
• Perform qualification of manufacturing and packaging equipment used in MDI production.
• Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Coordinate with Engineering, Production, QA, and Maintenance teams during qualification activities.

Utility Validation

• Qualification and validation of pharmaceutical utilities including:

• Compressed Air

• Nitrogen Systems

• Vacuum Systems

• Purified Water Systems

• Steam Systems

• Chilled Water

• Process Gases

• Prepare risk assessments and impact assessments for utilities.

HVAC & Environmental Validation

• HVAC System Qualification
• AHU Qualification
• Cleanroom Qualification
• Airflow Visualization Studies
• HEPA Filter Integrity Testing
• Air Velocity Measurement
• Differential Pressure Mapping
• Temperature Mapping
• Relative Humidity Qualification
• Recovery Studies
• Particle Count Qualification
• Environmental Monitoring Support

Process Validation

• Support Process Validation for MDI manufacturing operations.
• Execute validation batches.
• Analyze process performance.
• Review validation data and prepare reports.
• Coordinate with Production and QA teams.

Documentation

• Prepare and review:

• Validation Master Plan (VMP)

• User Requirement Specification (URS)

• Functional Specification (FS)

• Design Qualification (DQ)

• IQ/OQ/PQ Protocols

• Validation Reports

• SOPs

• Risk Assessments

• Change Controls

• Deviations

• CAPA Documentation

Regulatory Compliance

Ensure compliance with:

• cGMP
• GAMP 5
• USFDA
• MHRA
• EU GMP
• WHO GMP
• PIC/S Guidelines
• Data Integrity Requirements
• ALCOA+ Principles
• 21 CFR Part 11 (Preferred)

Cross Functional Coordination

• Work closely with QA, QC, Engineering, Manufacturing, Automation, and Maintenance teams.
• Participate in internal and external audits.
• Support regulatory inspections.

Required Qualifications

• Bachelor's Degree in:

• Mechanical Engineering

• Chemical Engineering

• Instrumentation Engineering

• Electrical Engineering

• Pharmacy

• Biotechnology

• Industrial Engineering

• Pharmaceutical Engineering

OR

Master's Degree in relevant discipline.

Experience

• 3–12+ years of pharmaceutical validation experience.
• Hands-on experience in MDI manufacturing is highly preferred.
• Experience in regulated pharmaceutical manufacturing facilities.
• Experience in greenfield/brownfield projects will be an advantage.

Technical Skills

Candidates should possess hands-on experience in:

Equipment Qualification

• IQ
• OQ
• PQ
• FAT
• SAT
• Commissioning Support

Validation

• Equipment Validation
• Utility Validation
• Process Validation
• Cleaning Validation (Preferred)
• Thermal Validation
• Temperature Mapping

HVAC Qualification

• AHU Qualification
• HVAC Validation
• HEPA Validation
• Recovery Tests
• Smoke Studies
• Airflow Pattern Studies
• Particle Count Studies

Documentation

• Validation Protocol Preparation
• Validation Reports
• SOP Writing
• Risk Assessment
• GMP Documentation
• Traceability Matrix

Regulatory

• USFDA
• MHRA
• EU GMP
• WHO GMP
• GAMP 5
• Annex 11 (Preferred)