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Lab Instrument Validation Engineer--San Diego, CA
Validation Engineer
San Carlos, CA

USDM Life Sciences is a leading global consulting firm focused on life sciences, specializing in regulated business processes, with an emphasis on compliance and performance. We are seeking a Sr Validation Engineer who has a strong background in the validation of lab instruments integrated with software. Experience with automated testing is also preferred.


Location: San Diego, CA


Will also support and need to have experience with:

Develop system validation scripts based on software/hardware configuration for enterprise systems:
• Work with facility Subject Matter Experts to document user requirements
• Update application system User Requirements, Functional, and Design Specifications
• Develop Installation Qualifications 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
• 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.
• Adhere to timelines
• Quick learner
• Expert in MS Word
• Able to multitask

 

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