AVINASH D. GHUGE

Key Responsibilities:

• Developed and reviewed PFDs, P&IDs, GA drawings, and equipment layouts for modular pharmaceutical facilities.
• Engineered process calculations including jacket design, heat transfer area (HTA), NPSHa, pump sizing, and clean utility line sizing.
• Prepared and reviewed process equipment specifications and data sheets for vessels, skids, clean utilities, and automation interfaces.
• Executed and reviewed DQ, FAT, SAT, IQ, and OQ protocols to ensure adherence to cGMP, Annex 11, and 21 CFR Part 11 standards.
• Led FAT activities focusing on system verification, riboflavin tests, drainability, dead leg analysis, MOC verification, and electronic data integrity checks to validate system performance.
• Collaborated with international stakeholders across multi-location projects.
• Supported proposal engineering and URS compliance mapping for global bids.

Key Project Exposure:

• Modular Biopharmaceutical Drug Substance Facilities
• Metered Dose Inhaler (MDI) Mixing Systems
• Small Volume & Large Volume Parenteral Systems
• Fermentation & Plasma Fractionation Systems
• Clean Utility & Process Skid Integration

Progressed from Engineer to Assistant Manager – Process Design

Key Responsibilities:

• Developed 60+ P&IDs, equipment layouts, and skid designs for pharmaceutical, biotech, plasma fractionation, SVP/LVP, and bioprocess facilities.
• Performed equipment sizing, jacket heat transfer calculations, SIP cycle time calculations, and utility load estimations.
• Engineered technical proposals based on URS, including deviation analysis, traceability matrices, cost estimates, and timelines.
• Prepared and reviewed DQ, FAT, IQ, OQ documentation and implemented risk-based qualification strategies (ISPE C&Q).
• Ensured compliance with USFDA, EU GMP, ICH, ASME BPE, and 21 CFR Part 11 requirements.
• Conducted FAT/SAT including control system validation, audit trail verification, electronic signature validation, and data integrity checks.
• Executed comprehensive system verification: riboflavin tests, drainability tests, hydro tests, dead leg verification, surface finish checks, MOC & molybdenum verification, welding inspection, vessel thickness checks, and dimensional/mechanical inspections.
• Performed alarm & interlock testing, power failure tests, emergency hold tests, safety valve checks, VFD parameter validation, I/O verification, and agitator/mixer trial runs.
• Verified user access control matrices, software licenses, electronic data storage systems, and security controls.
• Coordinated with piping, mechanical, and automation teams for integrated skid execution.
• Led client meetings, technical clarifications, board-level reviews, and non-compliance/corrective action reporting.
• Contributed to continuous departmental improvement through smart calculation methods and process optimization.

• Executed QA/QC activities for pharmaceutical process equipment and packaging systems, ensuring compliance with industry standards.
• Evaluated fabrication drawings, P&IDs, and technical specifications to verify adherence to manufacturing compliance requirements.
• Monitored welding quality, inspection stages, and pressure testing as per project quality plan.
• Conducted documentation audits and verified calibration certificates, test reports, and compliance records.
• Facilitated commissioning and validation documentation by preparing IQ/OQ protocols, executing checklists, and coordinating with validation teams.
• Ensured adherence to GMP requirements and client quality standards during project execution.

• Executed QA/QC inspections for fabrication of process vessels, tanks, and skid-mounted equipment as per approved drawings and project specifications.
• Performed welding inspections including fit-up verification, visual inspection, and WPS/PQR compliance checks; coordinated NDT activities (DPT/RT/UT) where applicable.
• Witnessed hydrostatic and pneumatic pressure testing in line with design codes and safety requirements.
• Verified Material of Construction (MOC) through MTC review, heat number traceability, and compliance with client-approved BOM.
• Conducted dimensional checks, surface finish inspection, and supported Factory Acceptance Tests (FAT).
• Prepared and compiled quality dossiers including inspection reports, test certificates, and final documentation for client submission.