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