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 robust 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.
- 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.
- 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