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 chance 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)

📌 Hvac And Utility Validation Engineer (Indore)
🏢 Forvis Mazars
📍 Indore