MAHESH BHASKARRAO MODHAVE

Successfully completed detail design engineering, procurement, FAT, SAT, IOQ of Downstream Process & support Equipments for 6 KLx6 Bioreactor scale-up mAb manufacturing project-1501 (Project Budget of USD 200 M) and 2 KL x 3 Bioreactor scale-up Single use mAb manufacturing project-1802 as per defined scope within budget, within schedule and with quality standards.

Single point contact (Package owner) from Project team for all internal and external stakeholders for reviewing, approving & floating URS, RFQ to vendors, reviewing and approving technical proposals with project scope, reviewing and finalizing commercial offers, Leading all techno-commercial discussions/meetings and follow up for timely submission of technical and commercial offers.

Responsible for performing Technical and Commercial bid analysis, preparing Technical recommendation reports and finalizing the vendor, co-ordinating with the commercial for PO process.

Reviewing, approving & coordinating with CFT and Vendor for timely approval of design documents, Datasheets of the components, Design qualification, RTM, FAT, SAT, IOQ protocols to ensure design accuracy and compliance with specifications during project design and execution stage.

§ Co-ordinating and reviewing project progress, identifying project risks, managing change controls for and recommend appropriate resolutions with vendor and CFT team through project review meetings.

§ Providing project progress status flagging any risk to allocated budget/ schedule/quality and suggesting the proper resolution on weekly basis to the management.

§ Co-ordinate with vendors, internal and external stakeholders for planning FAT, leading the FAT witness, giving dispatch clearance to vendor, support in installation and commissioning of the projects.

§ Lead MC, SAT and IOQ activity of the systems by coordinating internal and external stakeholders (CFT, Vendors, C and Q consultant). Addressing the critical roadblock by consulting with all stakeholders.

Continuously working on innovation in process design, process optimization, selection and implementation of latest technologies to reduce the COGS by savings on Capex and Opex for the project

§ Responsible for defining, positioning and proposing best suitable process designs utilizing Pall’s products and services based on client URS.

§ Executing the project from end to end i.e. from proposal engineering to system handover to client in line with company objectives of within specification, budget and within schedule.

§ To prepare the PFD, P&ID, equipment sizing calculations, mass balance, costing and design documents, FDS for Chromatography systems, Cassette/Hollow–fiber/Ceramic based TFF systems, Single use systems, DFF systems, VF systems, Water Filtration systems for upstream and downstream processes.

§ Timely completion of designs, requisitions and engineering deliverables.

§ Responsible to perform Pre –FAT, to coordinate and execute FAT of system with the customer, to attend and close any deviation or new request for change in system design.

§ Commissioning Responsibilities : System Installation & Commissioning, SAT, IQ/OQ, product process Optimization and handing over the systems at client place , Process troubleshooting support.

§ Continuously worked on innovation in design to optimize on the process and cost ensuring design solutions comply with safety, engineering and regulatory standards and guidelines.

§ Collate and present project data in the form of a monthly project report identifying project progress, cost projections, changes and risks to both internal and the client project team.

Co-ordinate proposal, procurement and project execution activities and communicate with internal team, vendors/suppliers and clients to maintain project progress in line with defined schedules

• Revised BOD for PCV production facility for modifications required wrt. Updated facility layout, Man-Material movement, Differential pressure and Area classification drawing, Utility requirement.
• Preparation of Process Flow Diagrams, Conceptual Layout with due regards to safe, easy plant operations, Project status reports, change control initiation and its compliance for this project.
• Prepared URS of Process vessels, CIP/SIP System, Continuous Centrifuge, Ultrafiltration Systems, Chromatography systems, Glove box, Filtration skids etc.
• Reviewed and approved all design documents and Datasheets of the components to ensure design accuracy and compliance with specifications during project design and execution stage.
• Participated in Client/Contractor meetings, resolving technical issues, preparation of MOM.
• Reviewing and pre-approving FAT, SAT, IQ, OQ, PQ, PV protocols, key member in FAT and SAT team.
• Interaction and communication with intra and inter-departments, project team members, clients and other external parties to ensure smooth coordination of project activities.
• Involved as a key person in production and optimization of WHO approved Meningococcal A (Men A) & Haemophilus Influenza type b (Hib) Vaccine at 100g and 75 g scale respectively.
• Involved in research and development work for overall product yield and quality optimization of Hib and Men A conjugation process and troubleshooting during scale- up studies.
• Successfully carried out engineering lot for production of Haemophilus Influenza type b (Hib) Vaccine at 225 g scale using conjugation skid.
• Authorized equipment /process SOPs, Batch manufacturing records, Technical summary reports, Product change over documents, Cleaning validation protocols, Process deviations and closing of the same during routine manufacturing.