Babu Selvaraj Email & Phone Number

Pune, Mh, In

Pune, Maharashtra, India

Pune, Maharashtra, India

Pune, Maharashtra, India

Bangalore

 Responsible for Initiation, Planning, Execution, Monitor & Control and closure of Biopharmaceutical projects. Co-ordination between cross functional team and client to review/approval of the processes. Prepare schedule and manage internal engineering disciplines and stakeholders to execute the project as per the timeline. Technical discussion and commercial negotiation for additional scope of the ongoing and new projects.

Bangalore

 Process engineering design & execution for Biopharma projects as per ASME BPE, US FDA (21 CFR Part 11) & ISPE guidelines. Conceptual design, Basic design and detail design documents review and approval for Biopharmaceutical projects. Process owner to review and approve the URS, P&ID, PFD and engineering drawings.

Tehran, Iran

 Lead the team to design and manufacture ASME BPE, cGMP compliance Biopharmaceutical equipment. Review and approve P&ID, PFD, SFC, Technical offer, BOM, FAT & SAT protocol documents, Valve matrix, URS, FRS and Operating manual documents. Lead the cross functional teams for the projects from the design stage to FAT, SAT (IQ, OQ & PQ) and after SAT services. Review and approve the documents involved in equipment and component manufacturing in compliance with cGMP, GEP and ASME BPE standards. Technical support to Business development team for prospective projects and preparation of techno-commercial offer. Technical support to customers for process improvement and efficient design for ease in automatic operation of complete Biopharmaceutical & related facility. Assist and manage the automation team for delivering best-integrated automation program in compliance with FDA 21 CFR, Part 11 for the Biopharmaceutical plant.

Bengaluru Area, India

 Execution of IQ, OQ, FAT and SAT for various upstream and downstream equipment. Prepare and review Design Qualification documents. Review IQ & OQ protocols and approve certificates. Review URS and assist in preparation of P&ID and BOM.  Review and approve P&ID and BOM. Prepare and review Technical offer, Valve matrix, Sequential flow chart (SFC), Functional specifications and Operating and Maintenance manual.

Hyderabad Area, India

 Recruited for first of its kind program in India for technology evaluation and validation and transfer of the same from Academia to Industry. Lead the project, work in collaboration with IKP Knowledge Park (Life Science Incubator) and CDFD to validate, improve and commercialize the technologies developed and patented by CDFD. Individually managed the commercial projects involving in Initiation, Planning, Executing, Monitor & Control and Closure of the complete project. Involved in troubleshooting during scale-up of “Improved recombinant bacterial strain for L-Arginine production”. Coordinate with Industry & Technology provider to scale-up the technologies and manage the project budget and Investor relationship.

Bengaluru Area, India

 Perform IQ and OQ during FAT and SAT. Prepare valve matrix, sequential flow chart, sequence matrix, operating manual and perform PLC simulation test, review SCADA program and approve for Pre-FAT. Verification of P&ID with As-built, General Assembly, isometric drawing and mechanical BOM, Spray ball coverage test, agitator test, drainability test, IQ & OQ protocol execution and Certificate verification.

Selected at National Level for Biotech Industrial training program sponsored by BCIL, Department of Biotechnology, Govt of India and trained in, Downstream Processing, Microbial Fermentation, Animal Cell Culture and Bioprocess Engineering

M.Sc, Biotechnology

B.Sc, Microbiology