Job Description – MDI Equipment & Utility Validation Professional

Position

MDI Equipment & Utility Validation Engineer / Senior Validation Engineer

Location

Indore, Madhya Pradesh (On-site)

Industry

Pharmaceutical | Life Sciences

Subject Line: Application – MDI Equipment & Utility Validation Engineer – Indor

e
About the Opportuni

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

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

s.
Key Responsibilit

iesEquipment Qualificat

- ionExecute Equipment Qualification activities including IQ, OQ, PQ, and requalificati
- on.Prepare, review, and execute Validation Protocols and Repor
- ts.Perform qualification of manufacturing and packaging equipment used in MDI producti
- on.Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SA
- T).Coordinate with Engineering, Production, QA, and Maintenance teams during qualification activiti

es.Utility Validat

- ionQualification and validation of pharmaceutical utilities includi
- ng:Compressed
- AirNitrogen Syst
- emsVacuum Syst
- emsPurified Water Syst
- emsSteam Syst
- emsChilled Wa
- terProcess Ga
- sesPrepare risk assessments and impact assessments for utiliti

es.HVAC & Environmental Validat

- ionHVAC System Qualificat
- ionAHU Qualificat
- ionCleanroom Qualificat




- ionAirflow Visualization Stud
- iesHEPA Filter Integrity Test
- ingAir Velocity Measurem
- entDifferential Pressure Mapp
- ingTemperature Mapp
- ingRelative Humidity Qualificat
- ionRecovery Stud
- iesParticle Count Qualificat
- ionEnvironmental Monitoring Supp

ort
Process Valida

- tionSupport Process Validation for MDI manufacturing operati
- ons.Execute validation batc
- hes.Analyze process performa
- nce.Review validation data and prepare repo
- rts.Coordinate with Production and QA te

ams.Documenta

- tionPrepare and rev
- iew:Validation Master Plan (
- VMP)User Requirement Specification (
- URS)Functional Specification
- (FS)Design Qualification
- (DQ)IQ/OQ/PQ Proto
- colsValidation Rep
- orts
- SOPsRisk Assessm
- entsChange Cont
- rolsDeviat
- ionsCAPA Documenta

tionRegulatory Compli

anceEnsure compliance w

- ith:
- cGMPGA
- MP 5U
- SFDA
- MHRAEU
- GMPWHO
- GMPPIC/S Guidel
- inesData Integrity Requirem
- entsALCOA+ Princi
- ples21 CFR Part 11 (Prefer

red)Cross Functional Coordina

- tionWork closely with QA, QC, Engineering, Manufacturing, Automation, and Maintenance te
- ams.Participate in internal and external aud
- its.Support regulatory inspecti

ons.
Required Qualifica

- tionsBachelor's Degre
- e in:Mechanical Engine




- eringChemical Engine
- eringInstrumentation Engine
- eringElectrical Engine
- eringPha
- rmacyBiotechn
- ologyIndustrial Engine
- eringPharmaceutical Engine

er

ingORMaster's Degree in relevant discip

line.
Expe

- rience3–12+ years of pharmaceutical validation exper
- ience.Hands-on experience in MDI manufacturing is highly pref
- erred.Experience in regulated pharmaceutical manufacturing facil
- ities.Experience in greenfield/brownfield projects will be an adva

ntage.
Technical

SkillsCandidates should possess hands-on experie

nce in:Equipment Qualif

- ic
- at
- io
- nIQ
- OQP
- QFATSATCommissioning

SupportVal

- idationEquipment Val
- idationUtility Val
- idationProcess Val
- idationCleaning Validation (Pre
- ferred)Thermal Val
- idationTemperature

MappingHVAC Qualif

- icationAHU Qualif
- icationHVAC Val
- idationHEPA Val
- idationRecover
- y TestsSmoke
- StudiesAirflow Pattern
- StudiesParticle Count

StudiesDocume

- ntationValidation Protocol Prep
- arationValidation
- ReportsSOP
- WritingRisk Ass
- essmentGMP Docume
- ntationTraceability

MatrixReg

- ulato
- ryUS
- FDAMHR
- AEU GMP
- WHO GM
- PGAMP 5Annex 11 (Pre

ferred)
Desired Comp

- etenciesExcellent analytical and problem-solving
- skills.Strong documentation and technical writing capab
- ilities.Effective stakeholder man
- agement.Good communication and presentation
- skills.Ability to manage multiple validation activities simulta
- neously.Team player with strong cross-functional collaboration
- skills.High attention to detail and quality

mindset.

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