Shivathmika Maheswaran Email & Phone Number

Greater Boston

Greater Boston Area

Project 4: Resilience, Cincinnati, OHProject 3: Tessera Therapeutics, Somerville, MAResponsible for developing CQV strategies for the newly onboarded manufacturing and QC equipment. Project 2 (Sanofi, Framingham, MA):•Served as the lead for all execution activities, leading a team of 5 CQV engineers in a fast-paced high visibility CQV project. •Pushed execution activities and discrepancies/retests to completion, for systems, equipment and utilities.•Generated commissioning and qualification protocols for process equipment and clean utilities using Kneat paperless validation software at the Pompe ICB project.•Generated Design Qualifications for process equipment.Project 1 (Siemens Healthineers, East Walpole, MA):-Led the qualification and validation of cleaning equipment (CIP skids and parts washers)• Developed strategies for cleaning cycle development studies, and cleaning validation protocols. Responsible for compilation of data, interpretation of results, and preparation of final reports for cleaning validation activities.• Collaborated with cross-functional team to create risk assessments pFMEA’s for several process equipment.• Coordinated with Engineering, Manufacturing and Quality for timely approvals of CQV deliverables.• Performed peer review of CQV protocols.• Trained junior engineers on the execution of cleaning validation and other qualification protocols.• Involved in executing SAT protocols, Design Qualification, and IQ/OQ/PQ protocols.• Troubleshooting CIP processes and new cleaning equipment with site-engineering group.• Trained manufacturing operators on process equipment SOP’s.• Assisted investigation of non-conformity and authored CAPA’s.• Coordinated with Meteorology department to schedule Calibration and Maintenance activities. Assisted in the development of maintenance procedures for new equipment.

Greater San Diego Area

Project 1: The project focused on development, remediation and validation of various cleaning processes.Responsibilities: • Developed and revised company’s global procedures for cleaning validation and verification.• Authored cleaning validation/remediation plans for the validation of various cleaning processes and determined product/equipment grouping strategies. • Created swab and rinse sampling work instructions and hosted hands-on sampling training sessions.• Developed and executed swab/rinse recovery studies to determine recovery factors. • Developed and validated a non-specific analytical method (TOC) for the analysis of cleaning validation samples• Investigated non-conformances and deviations related to cleaning issues in manufacturing areas. Project 2: The scope of this project included validation of various manufacturing Fill and Finish systems. Responsibilities:• Created validation plan, URS, FRS, FMEA, IQ, OQ and PQ• Completed 21 CFR Part 11 and cGMP assessments • Investigated and resolved deviations.• Created validation summary reports and RTM to summarize validation activities. • Provided support for onboarding and calibrating new equipment per company standards.

Chennai Area, India

Chennai, Tamil Nadu

Intern @ Rail Neer water purification site.

Master Of Science - Ms, Chemical Engineering

Bachelor Of Technology - B.Tech, Chemical Engineering