Hi, I’m Hari Karthik S, a Process, Automation & CQV Engineer with 6.5+ years of experience in biopharmaceutical manufacturing and greenfield & brownfield project execution across India, Denmark, and Malaysia. My core strength lies in bridging Process Engineering, Automation, and Validation, ensuring that equipment and control systems are designed, integrated, and qualified in line with GMP and regulatory expectations. I have hands-on experience with DeltaV, Siemens PCS7, and ABB 800xA, working on ISA-88 based recipe design, equipment module structuring, EM matrix development, phase testing, and automation-integrated CQV execution. From a process engineering perspective, I’ve worked extensively on upstream and downstream biologics equipment—including bioreactors, chromatography skids, TFF systems, CIP systems, buffer preparation/hold tanks, and filtration systems. My experience includes URS/FRS development, facility fit studies, P&ID reviews, technology transfer support, process optimization, and troubleshooting during commissioning and validation. I’ve contributed to projects for organizations such as Biocon Biologics, Novo Nordisk, NNE, and global consulting teams, supporting FAT, SAT, IQ, OQ, PQ, cleaning validation, and risk-based qualification (ASTM E2500, ISPE). On Topmate, I help with: 🏭 Process Engineering in Biopharma (upstream & downstream concepts, equipment, facility fit) 🤖 Automation & ISA-88 (recipes, phases, EM matrix, control strategy) ✅ CQV execution (FAT/SAT, IQ/OQ, documentation & compliance) 📄 Career guidance (resume review, interviews, project exposure in biopharma) If you’re looking to build a strong foundation in Process Engineering, Automation, or CQV within the biopharmaceutical industry, I’d be happy to help you navigate the journey.