Building Management Systems Engineer
Forvis Mazars · Indore · onsite · Posted 71d ago
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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)
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
Sourced from foundit
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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