Indotronix Avani Group · 2 days ago

Validation Engineer

Exton, PA

Contract

Hybrid

Mid Level

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Hiring Manager

Srinadh Garbhapu

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Responsibilities

Design, create, plan, and execute the site validation plan for all GxP computer systems and software at the new DSM Biomedical Devon site project.

Lead software validation implementation and any additional QA requirements through effective planning of set up, design, and testing for the project.

Create, modify, and organize all related and required documentation for the validation of the software and computer systems for the project.

Work with project team to document user requirements.

Work with vendors to collect functional specifications.

Modify, amend previously executed validations for the existing systems as needed.

Work with the business and vendors to create test scripts and coordinate with the team to execute the testing.

Deliver validation final report out for each system implemented and full site go-live.

Perform Computer System Validation (CSV) of specified software applications for GMP use at the Devon plant.

Qualification

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Validation PlansGlobal Regulation RequirementsValidation DocumentationUser Requirements DocumentationFunctional Specifications CollectionTest Scripts CreationTesting CoordinationComputer System Validation (CSV)

Required

Experience in designing, creating, planning, and executing validation plans for computer systems and software

Knowledge of global regulation requirements for computer system validation

Ability to create, modify, and organize validation documentation

Experience in documenting user requirements and collecting functional specifications

Experience in creating test scripts and coordinating testing

Experience in Computer System Validation (CSV) for software applications

Company

Indotronix Avani Group

The Indotronix Avani Group is an award-winning staffing, consulting, and technology solutions company with a footprint across the United States, Canada, and India.

Founded in 2016