Venkata Maremanda
QE Validation Engineer laboratory Instruments @ API, CDMO cell & gene therapy
- Role
- Qe Validation Engineer- Laboratory Instruments at Pfizer
- Location
- Rocky Mount, NC, US
- LinkedIn followers
- 500 followers
About Venkata Maremanda
QE Validation Engineer with experience validating laboratory instruments in regulated environments. Expertise in IQ/OQ/PQ, validation protocols, compliance testing, and quality documentation. Strong collaborator with cross-functional teams to ensure products meet regulatory and performance standards. Committed to quality, data integrity, and continuous improvement.At catalent(CDMO)our team focuses on ensuring the seamless operation of systems critical to biopharmaceutical development. As a Senior Validation Engineer, I take the lead in developing validation plans and documentation, harmonizing efforts with industry standards such as GxP and CFR Part 11. Our work involves rigorous validation of systems like LIMS and MES, supported by my proficiency in tools like Veeva and ValGenesis.Previously, we have spearheaded risk assessments and validation strategies at companies like AbbVie and Abbott, emphasizing compliance and quality. With a foundation in Computer System Validation and a knack for aligning processes with regulatory demands, I am committed to driving innovation and quality in the complex realm of equipment validation. My approach blends meticulous documentation with strategic compliance, ensuring the integrity and reliability.
Experience
Qe Validation Engineer- Laboratory Instruments
Nov 2025 — Present · Rocky Mount, NC, US
validation efforts for laboratory instruments including HPLC, GC, MS, Osmometers, and automated analyzersAuthored and executed IQ/OQ/PQ protocols, validation plans, and summary reportsUtilized tools such as JIRA, ALM, and Excel for test management and defect trackingIdentified root causes of failures and worked cross-functionally to implement corrective actionsEnsured adherence to ISO 13485 / ISO 17025 requirements throughout validation lifecycle
Education
Gayatri Vidya Parishad College of Engineering (Autonomous)
Bachelor of Technology - BTech, Chemical Engineering
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