Hvac Engineer
Forvis Mazars · Indore · onsite · Posted today
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About this role
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
Joining
Immediate Joiners Preferred (030 Days Notice Period)
Subject Line: Application MDI Equipment & Utility Validation Engineer – Indore
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)
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Skills
About Forvis Mazars
Forvis Mazars
Accounting & Auditing
About
Forvis Mazars Group - Audit, Tax, Advisory
Forvismazars.com
Forvis Mazars is a leading global professional services network established on 1 June 2024 bringing together the previously known Mazars and FORVIS companies. We are a network operating as an internationally integrated partnership across more than 100 countries and territories. We draw on the expertise and cultural understanding of over 40,000 professionals across the globe to assist clients of all sizes at every stage in their development. Forvis Mazars in the UK spans 14 offices across the nation and has over 3,300 professionals, with 170 partners.
You will join a growing team of over 750 relationship-driven, curious, problem solvers who add value to their clients on a daily basis. Our expertise ranges from servicing private, entrepreneurial companies through to UK listed companies, financial services clients and some of the largest FT Global organisations in the world.
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Work-life
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