PROJECTS PORTFOLIO

---

• Developed the CMMS asset list for all HVAC systems, ensuring structured asset tracking and maintenance integration
   
• Participated in W2, W3, and Mechanical Completion (MC) walkdowns to verify as-built systems matched design intent
   
• Coordinated with the CQV SWAT Team for punch-list closure during pre-MC and CQV execution phases
  
   

• Supported execution of Pre-Startup Safety Review (PSSR) and Startup Work (STW) field activities
   
• Led the CQV team through system startup in a safe and controlled manner
   
• Ensured readiness of HVAC systems for qualification and turnover
   

• Executed FAT, SAT, and IOQ protocols for HVAC systems and cleanroom areas
   
• Liaised with vendors to perform BMS and VDS alarm testing across 37 AHU units
   
• Conducted cleanroom environmental testing including:
   
  • HEPA integrity testing (DOP/PAO)
     
  • Differential pressure (DP) cascade verification
     
  • Airflow volume and air exchange rate calculations
     
  • Pressure recovery time validation
     
  • Temperature and humidity stability testing
     
  • Lux level verification
     
  • Interlock functionality tests
     

• Collaborated with the Process Support Equipment Team to create:
   
  • URS, RTM, and Commissioning Test Protocols
     
  • Equipment coverage included:
     
    • Biosafety Cabinets
       
    • Laminar Airflow Units
       
    • CO₂ Incubators
       
    • Waverockers
       
    • Freezers and Cold Rooms
       

• Supported the CSA Team in the development of Room Data Sheets (RDS) for cleanroom qualification
   
• Ensured alignment between classified area requirements and HVAC design/commissioning outputs
   

• Developed and reviewed User Requirements Specifications (URS) and Requirements Traceability Matrix (RTM) for HVAC systems, including classification zones (Grade C–D)
   
• Ensured traceability between design intent and qualification deliverables for all critical cleanroom environments
   

• Commissioned HVAC systems including AHUs, terminal HEPA filters, dampers, and ductwork
   
• Participated in Testing & Balancing (TAB) activities to ensure airflow volumes met design requirements
   
• Coordinated Site Acceptance Testing (SAT) for HVAC controls, Building Management System (BMS), and Ventilation Distribution System (VDS)
   

• Drafted and executed Commissioning, IQ, and OQ protocols for AHUs, room pressure control, and environmental systems
   
• Performed cleanroom validation including:
   
  • Differential Pressure (DP) cascading
     
  • Airflow patterns and volume verification
     
  • Air Changes Per Hour (ACPH) compliance
     
  • HEPA filter integrity testing (DOP/PAO)
     
  • Pressure recovery time studies
     
  • Particle count tests (at rest and in operation)
     
  • Temperature & humidity control validation
     
  • BMS/EMS alarm verification for critical environment parameters
     

• Supported execution of Pre-Startup Safety Review (PSSR) and Startup Work (STW) processes
   
• Facilitated safe and compliant handover of HVAC systems for GMP production use
   

• Collaborated with vendors, contractors, and cross-functional teams to resolve punch lists and complete CQV lifecycle
   
• Supported final system release and documentation handoff for operational readiness
   

• Developed and reviewed Room Data Sheets (RDS) aligned with HVAC zoning and control strategies
   
• Documented deviations, performed impact assessments, and coordinated CAPA implementation
   
• Contributed to regulatory inspection readiness by ensuring traceability and completeness of CQV documentation for audits (EMA, FDA, WHO)

• Review and comment on P&IDs, layout drawings, ductwork diagrams, and airflow schematics
   
• Participate in Design Review (DR) meetings and support DQ creation for HVAC systems
   
• Contribute to Risk Assessments and Impact Assessments for HVAC components and controls
   
• Assist in defining environmental classification zones (Grade C/D) based on process requirements
   

• Supervise installation and pre-commissioning checks of AHUs, filters, ducts, dampers, and sensors
   
• Execute functional checks on motorized dampers, air valves, VAVs, and VFDs
   
• Verify mechanical completion (MC) and punch list closure
   
• Support air balancing and flow verification for classified and non-classified spaces
   

• Draft, review, and execute IQ/OQ protocols for HVAC systems and associated controls
   
• Conduct HEPA filter integrity tests (DOP/PAO) and particle count validations
   
• Perform differential pressure measurements, air velocity checks, and recovery time studies
   
• Verify temperature & humidity control, alarm setpoints, and interlock functionality
   
• Oversee BMS/EMS testing, including communication protocols, data trending, and fail-safe verifications
   

• Develop and maintain validation deliverables: URS, RTM, VMP, Validation Plan, Test Protocols, Final Reports
   
• Ensure alignment with GMP documentation practices and data integrity (ALCOA+ principles)
   
• Document and investigate deviations, and support CAPA implementation
   
• Support preparation for regulatory inspections (EMA, FDA, WHO) by ensuring full traceability
   

• Coordinate with cross-functional teams: Process, QA, BMS, Automation, Cleanroom, and Utility teams
   
• Engage with vendors for FAT/SAT execution and post-installation troubleshooting
   
• Train and support junior engineers or QA staff on CQV procedures and GMP expectations
   
• Facilitate PSSR (Pre-Startup Safety Review) and handover procedures to operations

• Review and develop User Requirement Specifications (URS) and Design Qualification (DQ) protocols for a wide range of equipment, including:
   
  • Biosafety Cabinets (BSC)
     
  • Laminar Airflow Units (LAF)
     
  • CO₂ Incubators
     
  • Autoclaves / Steam Sterilizers
     
  • Freezers (−20°C, −80°C)
     
  • Cold Rooms / Walk-in Chambers
     
  • Waverockers / Shakers / Mixers
     
  • Centrifuges (Benchtop and Floor-standing)
     
  • pH/Conductivity Meters
     
  • Balance Scales / Analytical Balances
     
  • Dry Heat Ovens
     
  • Humidity Chambers / Stability Chambers
     
  • Washers
     
  • Vortex Mixers
     
  • Refrigerated Centrifuges
     
  • Vacuum Pumps and Manifolds
     
  • Peristaltic and Diaphragm Pumps
     
  • Pass Boxes / Dynamic Pass-Through Chambers
     
  • Small-scale Bioreactors / Fermenters (supporting QC labs)
     
  • Laboratory refrigerators for temperature-sensitive materials

• Conduct Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) in collaboration with vendors and project stakeholders
   
• Verify correct installation through as-built checks, utility connection verification, and material compatibility reviews
   
• Perform instrument calibration checks (temperature, pressure, RPM, etc.) as part of commissioning testing
   

• Draft, review, and execute Installation Qualification (IQ) protocols, verifying:
   
  • Equipment model & serial numbers
     
  • Utility connections (electrical, compressed air, water, drain)
     
  • Calibration certificates and component part lists
     
• Develop and execute Operational Qualification (OQ) protocols to verify:
   
  • Safety interlocks, alarms, cycle performance, user interface functionality
     
  • Temperature mapping, run cycle consistency, and auto-shutdown/startup functions
     
• When required, support Performance Qualification (PQ) in collaboration with QA/Production
   

• Conduct temperature mapping studies using calibrated data loggers in:

• Incubators, freezers, cold rooms, ovens, stability chambers
   
• Validate uniformity and distribution according to:
   
  • ISPE guidelines, EU GMP Annex 15, and ICH Q1A
     

• Create and maintain a full set of CQV documentation including:
   
  • Validation Master Plan (VMP)
     
  • Traceability Matrix (RTM)
     
  • Test Protocols (IQ/OQ/PQ)
     
  • Summary & Final Reports
     
• Ensure data integrity (ALCOA+) across all records and documentation
   
• Review vendor documents such as P&IDs, wiring diagrams, user manuals, and maintenance SOPs
   

• Identify and document any deviations from protocol specifications
   
• Perform impact assessments, propose corrective/preventive actions (CAPA), and support re-testing where needed
   
• Evaluate changes to equipment configuration and determine requalification needs
   

• Develop and review User Requirement Specifications (URS) for standalone GMP equipment ensuring alignment with process needs, regulatory standards, and risk-based validation approaches
   
• Define critical design parameters and performance attributes to ensure equipment is suitable for intended use
   
• Participate in Design Qualification (DQ) reviews and provide technical validation input during procurement
   

Standalone equipment typically includes:

• Benchtop Centrifuges

• Motor Pumps

• Palletanks
   
• pH and Conductivity Meters
   
• Analytical Balances
   
• Water Baths
   
• Vortex Mixers
   
• Refrigerators and Freezers
   
• Shakers, Rockers, Magnetic Stirrers
   
• Glassware Washers / Dryers
   
• Microscopes
   
• Ovens
   
• Label Printers & Barcoding Equipment
   
• Manual Sealers / Crimpers
   
• Power backup systems (UPS, portable gensets)
   

• Oversee installation verification including physical placement, utility connection checks, and labeling (asset tags, calibration status)
   
• Ensure vendor manuals, calibration certificates, and spare part lists are available and compliant
   
• Execute pre-functional checks for mechanical, electrical, and software components (if applicable)
   

• Draft and execute:
   
  • Installation Qualification (IQ): Verifying physical attributes, documentation, and utility connections
     
  • Operational Qualification (OQ): Verifying operational controls, display accuracy, alarm responses, and auto-cycles
     
  • Performance Qualification (PQ): When applicable, simulate actual use conditions to ensure consistent performance
     
• For instruments like balances and pH meters, perform calibration with certified standards and verify repeatability/linearity
   

• Perform or verify calibration of:
   
  • Temperature sensors (in incubators, ovens)
     
  • pH electrodes
     
  • Balances (using calibrated weights)
     
• Conduct temperature mapping for cold storage or heating equipment as per ICH Q1A and WHO TRS 961
   
• Verify alarm testing and threshold limits (e.g., for freezers, refrigerators)
   

• Create and maintain validation documentation including:
   
  • URS, RTM, IQ/OQ/PQ protocols, summary reports
     
  • Equipment SOPs and Work Instructions
     
• Ensure data integrity compliance with ALCOA+ principles
   
• Archive vendor manuals, installation drawings, and training certificates as part of validation dossier
   

• Document deviations encountered during qualification execution
   
• Perform impact assessments, propose CAPAs, and oversee requalification when required
   
• Review equipment changes post-installation (firmware updates, part replacement) and initiate change control as needed
   

• Coordinate with:
   
  • QA for protocol review/approval
     
  • IT for data storage and compliance (if equipment is networked)
     
  • Facilities and Engineering for utility provision and integration
     
• Support training of operators and QA in handling standalone equipment post-qualification

• Revised and aligned validation documents with current GMP and internal quality standards
   
• Reviewed and updated IQ, OQ, PQ protocol templates and compiled Final Summary Reports
   
• Developed clear and testable acceptance criteria based on URS and regulatory guidelines
   
• Defined optimal validation strategies, coordinated task assignments, and ensured timely execution
   

• Established cross-functional validation teams involving QA, engineering, and production personnel
   
• Advised on creation and revision of Work Instructions (WI) and Quality Records (QRs) based on process validation results
   
• Evaluated change requests and determined the need for revalidation or impact assessment
   

• Reviewed and commented on validation documents submitted by UK-based validation engineers
   
• Ensured all qualification documentation adhered to regulatory expectations and engineering best practices
   

• Collaborated with process owners and technical departments to execute:
   
  • Factory Acceptance Testing (FAT)
     
  • Site Acceptance Testing (SAT)
     
• Supported qualification and validation for lab and process equipment, including:
   
  • Ovens, Humidity Chambers, Autoclaves, Freezers, and other temperature-sensitive equipment
     

• Conducted impact assessments, root cause analysis, and implemented corrective/preventive actions (CAPAs) for deviations found during validation
   
• Ensured seamless process development and technology transfer based on validated engineering principles and regulatory compliance