Sivi Sasidharan
CSV | CSA | IT-QA | SDLC | GAMP 5 | Regulatory Compliance
- Role
- Quality Engineer at Deloitte
- Location
- Hillsborough, NJ, US
- LinkedIn followers
- 500 followers
About Sivi Sasidharan
A seasoned Pharma CSV and Quality professional with around 12 years experience across Pharma Consulting, IT Services and Pharma companies.\\ Strong experience in project and team management, both as an individual contributor as well as leading, managing and mentoring teams for multiple complex global engagements for Pharma leaders across US, Europe and India\\ Experience in validation of RPA solutions (UiPath) and Category 3, 4 and 5 software\\ Expertise in GAMP 5, 21 CFR Part 11, Annex 11\\ Hands on experience using HP ALM, Veeva QualityDocs, ComplianceWire, Trackwise, ServiceNow, Jira, Confluence, Xray for Jira
Experience
Quality Engineer
Oct 2025 — Present · NJ, US
Client: Johnson & Johnson
Education
MET'S School of Engineering
B.Tech, Biotechnology
2003 — 2007
Sathyabama University
M.Tech, Biotechnology
2008 — 2010
Skills
- Sds-Page
- Plc Validation
- Filtration
- Gmp
- Chromatography
- Affinity Chromatography
- Bioprocessing
- Computer System Validation
- Cell Culture
- Csv
- Gamp
- Downstream Processing
- Biopharmaceuticals
- Biotechnology
- Cell
- Validation
- Purification
- Fermentation
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