Ahmedabad, Gujarat, India
Passionate Biochemical Engineer. 🔷 Working as Process Engineer, Detailed Equipment Design, Project Execution, Quotation and Cost Estimation. 🔷 Have hands on experience in Cell Culture Downstream operations and equipment commissioning and qualifications at various scales 2kl, 6kl., 👉Strengths : P&ID, Line Sizing, Components Selection, C&Q, Equipment Cleaning Validation, TFF, Chromatography (ILC, PK), Column Packing, Single Use Operations. 👉cGMP Documentation: QMS, BMR(BR, WI), SOPs, Deviations, Change Control, Deviation closure, Regulatory Compliance. 👉Software: CCP, Unicorn 7.3, WinCC,SAP, Honeywell 👉Onco Products: BmAb, TmAb, Fusion mAbs, etc 👉Knowledge/ Certification pursuit : Process validation, PMP, Six Sigma
Process Engineer
-Execution of SAT, IQ, OQ, and PQ of In-Line Chromatography system (GE-Cytiva), and TFF (2 Cross Flow systems-Sartorius Stedim). -Equipment and Process related document preparation such as SOP, BMR, PPQ Protocols. -Execution of downstream process activities for engineering, developmental, PV, and commercial batches. -Micro planning and Pre planning for daily assigned activity, assign required manpower, shift planning
-Commissioning and qualification of equipment such as TFF, VF Skid, Chromatography system, Filling station, Freeze and Thaw system and table top equipments. -Preparations of documents SOP, BMR, PQ Protocols, URS, RTM, study protocols, risk assessment and mitigation. -Operation of various unit operations like: Chromatography, UF/DF, Viral Filtration, Freeze- Thaw, & Filling Station. -Fulfilling prerequisites for column packing, column evaluation -Preparing formulated drug substance (Excipients preparation & handling of Formulated Bulk). -Can Assists with diagnosing and trouble-shooting of operational issues, investigation of process failures & to find out the root cause, deviation initiation, change controls in coordination with other cross-functional teams for successful implementation. -Developed key skill in resolving gaps in unit operations through batch reviews.
Assisted in development Biofertilizers and Amino acid, Protein Hydrolyzate formulations. Development of new crop oriented schedules and mode of applications.