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Simon Lasisi
Quality Systems-Computer Systems Validation Manager, Intuitive Surgical Location: Sunnyvale, CA United States Joined: Mar 23rd, 2026 |
| About (request update) | |
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| Experience |
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I currently work with Intuitive Surgical
as Quality Systems-Computer Systems Validation Manager I have 20 years of experience working in the Other industry. |
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Quality Systems-Computer Systems Validation Manager |
Intuitive Surgical
From January 2018 to December 2024 • 6 year(s) Owned responsibility for computer systems validation processes, reviewed and approved computerized systems for GxP purposes, provided compliance guidance and training |
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Quality Systems-Computer Systems Validation Manager |
Intuitive Surgical
From January 2018 to January 2024 • 6 year(s) Owned responsibility for multiple computer systems validation processes and provided compliance guidance and training on various validation methodologies. |
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Project Manager/Validation Specialist |
Total Compliance Services
From January 2016 to December 2017 • 1 year(s) Led and mentored staff of up to 20, managed concurrent validation projects for equipment like ICP-MS, auto-samplers, and microwave digestion systems |
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Project Manager/Validation Specialist |
Total Compliance Services
From January 2016 to January 2017 • 1 year(s) Led and mentored staff of up to 20 and managed concurrent validation projects for equipment like ICP-MS, auto-samplers, and microwave digestion systems. |
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Computer Validation Specialist |
Pfizer
From January 2015 to December 2016 • 1 year(s) Ensured spreadsheet validations in QC Laboratories, managed CFR Part 11 and 211 implementations |
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Computer Validation Specialist |
Pfizer
From January 2015 to January 2016 • 1 year(s) Ensured spreadsheet validations in QC Laboratories and managed CFR Part 11 and 211 implementations. |
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Computer Validation Specialist |
Tumero Cardiovascular
From January 2012 to December 2013 • 1 year(s) Managed retrospective validation actions after FDA consent decree, trained medical devices staff on compliance regulations |
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Computer Validation Specialist |
Tumero Cardiovascular
From January 2012 to January 2013 • 1 year(s) Managed retrospective validation actions after an FDA consent decree and trained medical devices staff on compliance regulations. |
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Computer Validation Lead |
Sandoz Pharmaceuticals
From January 2012 to December 2012 • 0 year(s) Oversaw validation programs for laboratory and manufacturing computerized systems |
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QA Map Specialist |
Google
From January 2011 to December 2012 • 1 year(s) Managed quality assurance and accuracy of geographical location maps, collaborated with map engineers to improve map accuracy |
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Computer Validation Lead |
Sandoz Pharmaceuticals
From January 2012 to January 2012 • 0 year(s) Oversaw validation programs for laboratory and manufacturing computerized systems. |
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QA Map Specialist |
Google
From January 2011 to January 2012 • 1 year(s) Managed quality assurance and accuracy of geographical location maps while collaborating with map engineers to improve map accuracy. |
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QA Computer Validation Lead |
Bayer Health Care
From January 2008 to December 2011 • 3 year(s) Owned responsibility for computer validation processes in R&D and manufacturing, managed approval and review of QA policies, programs, SOPs |
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QA Computer Validation Lead |
Bayer Health Care
From January 2008 to January 2011 • 3 year(s) Owned responsibility for computer validation processes in R&D and manufacturing, managed Quality assurance policies and provided compliance training. |
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QA Computer Validation Lead |
Genentech
From January 2007 to December 2008 • 1 year(s) Validation of computerized systems for clinical trials data |
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QA Computer Validation Lead |
Genentech
From January 2007 to January 2008 • 1 year(s) Validation of computerized systems for clinical trials data. |
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IT Validation Lead |
Novartis
From January 2007 to January 2007 • 0 year(s) Validation lead for Novartis/Bayer Schering Pharma IT integration project and validation coordinator for scientific systems. |
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Computer Validation Lead |
Nektar Therapeutics
From January 2004 to January 2007 • 3 year(s) Directed validation of computer systems including manufacturing control networks and implemented 21 CFR Part 11 and Sarbanes-Oxley compliance. |
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Computer Validation Specialist |
GlaxoSmithKline
From January 2003 to January 2003 • 0 year(s) Computer validation, authored test case scripts and conducted 21 CFR Part 11 assessment of Cognos database for preclinical data studies. |
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Clinical QA Auditor |
Pharmaceutical Products Development
From January 1999 to January 2000 • 1 year(s) Conducted thorough reviews of various drug studies including data management, validation manuals, and quality control checks. |
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Technical Author |
GlaxoSmithKline
From January 1999 to January 1999 • 0 year(s) Revised, rewrote, and created new SOPs for migration from legacy QAURTS system to new LIMS integration. |
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Validation Coordinator |
GlaxoSmithKline
From January 1999 to January 1999 • 0 year(s) Performed validation review of data migration protocols for SAP as part of MRPII project applying GAMP and 21 CFR Parts knowledge. |
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Validation Coordinator |
GlaxoSmithKline
From January 1998 to January 1999 • 1 year(s) Facilitated validation using validation master plans and IQ/OQ/PQ for production and R&D equipment, troubleshooting production equipment. |
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Formulation Scientist |
AstraZeneca/Sanofi-Aventis
From January 1997 to January 1998 • 1 year(s) Formulation of pharmaceutical products including Angina tablets and contraceptives, following GLP and analytical methods. |
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