– MDI Equipment & Utility Validation Professional

Position

MDI Equipment & Utility Validation Engineer / Senior Validation Engineer

Location

Indore, Madhya Pradesh (In office)

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 strong 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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