Job Openings | USDM Careers



Validation Engineer- SaaS
Validation - CSV
Pleasanton, CA

USDM is  looking a strong Validation resource to support validation projects for cloud based (SaaS) clinical applications and lead the efforts of offshore testing support.

Job Description
• Develop and execute system validation scripts based on software/hardware configuration for enterprise systems
• Update application system User Requirements, Functional, and Design Specifications
• Develop Installation Qualifications scripts based on Design
• Develop Operation Qualifications based on functional requirements
• Develop Performance Qualification scripts based on configuration
• Route validation documentation
• Manage Tasks based on aggressive timelines
• Interact with customers at multiple sites
• Interact in team environment

Qualifications
• Experience with validation implementation, preferably clinical systems knowledge.
• 3-5 years of experience, with some lead exp.
• Minimum BA / BS or relevant work experience in information systems,
engineering, science or business.
• Validation experience with computerized systems in the pharmaceutical industry.
• Excellent oral and written communication skills.
• Strong technical background – familiar with writing queries
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
• Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
• Ability to work independently with minimal supervision.

 

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