Validation Engineer Resume , Rockaway, New Jersey - Hire IT People

SUMMARY:

A Validation Engineer with 4.5+ years of Computer System Validation expertise, with previous experience of leading Remediation Projects specific to 21 CFR Part 11, highly skilled at technical writing of validation deliverables, and document management.
A Certified Quality Engineer with knowledge of Six Sigma and Lean methodologies.

TECHNICAL SKILLS:

Programming: Highly proficient with the usage of C language, C ++, Visual Basic, Python, SQL and

Computer Skills: Highly skilled in using MATLAB, Mathematica, data analysis using Labview3 - D CAD modeling and product prototyping using Solidworks and ANSYSand being responsible for administrative duties using Microsoft Office

Technical Skills: -Extensive knowledge of FDA regulations, GxP guidelines, Computer System Validation (CSV) principles and creating, reviewing and approving validation deliverables as per the SDLC cycle.

Language Skills: Highly skilled in English verbal and written communication, native fluency in Hindi and Urdu, proficient in written and spoken German and Spanish

PROFESSIONAL EXPERIENCE:

Validation Engineer

Confidential, Rockaway, New Jersey

Responsibilities:

Responsible for the Validation effort behind the Duplication and Scrub of
LabWare LIMS v5, Empower Archiving using NuGenesis, and BMRAM Implementation.
Conducted test script execution, review and approval for test scripts covering data migration mapping for the ARISg to Argus migration project. Supported creation of Change Plans, drafted and reviewed Installation and Operational
Qualification test scripts, Summary Memos for the Trackwise Archiving Project.
Preparing and routing change control requests and risk assessment forms for review and approval from requisite stakeholders, ensuring successful completions within project timelines. Maintaining timely documentation and archiving for all validation deliverables utilizing Coral (Documentum) and SharePoint.

Validation Analyst

Confidential, Rockville, Maryland

Responsibilities:

Successfully completed a 21 CFR Part 11 Remediation project involving extensive GAP
Analysis, Corrective and Preventive action, negotiating FDA and internal audits successfully.
Creation of Validation Plans, Operational and Performance Qualification test scripts, interfacing with end users to complete User acceptance testing and provide Production environment support. Led and managed a team of 4 offshore Validation Engineers to finish validation deliverable documentation and archiving for the SharePoint and QC ALM document management systems.

Biomedical Assistant

Confidential, Ithaca, New York

Responsibilities:

Responsible for biomedical equipment inventory and preventive maintenancef biomedical equipment belonging to the center. Performed all the requisite administrative duties of a typical healthcare environment, including rganizing and analyzing potential investors’ data for preparing investment criteria

Associate Software Engineer

Confidential

Responsibilities:

Trained in SQL and its applications, and documented and maintained database system specifications, diagrams, and connectivity chart.

Biomechanics Intern

Confidential

Responsibilities:

Simulated using Finite Element Modeling, the interaction of an AFM with the cellular membrane to characterize its mechanical properties Utilizing Python programming, was able to optimize AFM diameter values for maximum surface area contact, consequently utilized in an experimental set - up

Biomedical Intern

Confidential

Responsibilities:

Facilitated implementation of a biomedical equipment tracking system which helped the biomedical department maintain an accurate inventory Trained on the various functionalities and maintenance of hospital equipment by doctors and application specialists

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Validation Engineer Resume

Rockaway New, JerseY

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