Life Sciences Validation Specialist
ABOUT SAPIO SCIENCES
Sapio Sciences is the leader in Digital Transformation accelerating R&D in the life science industry. Sapio provides LIMS, ELN, and Scientific Data Management Solutions through its flexible, scalable, and easy-to-use Seamless Informatics Platform. Sapio Sciences was founded in 2004 with the mission to empower scientists and streamline the scientific discovery process. The company is headquartered in Baltimore, MD, with satellite offices in San Diego, CA, Ft. Lauderdale, FL, and York, PA.
- Develop computer systems validation documentation including validation plans, qualifications test protocols and test scripts, traceability matrices, summary reports and all documents and deliverables within the scope of the validation plan
- Execution of validation plans and validation documents
- Write, execute, and review IQ, OQ, PQ test scripts
- Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
- Assist with the development of user requirements and specifications to ensure requirements are testable and requirements are met
- Interact with the internal and customer project teams to provide expertise on all validation activities
- Write Change Controls as needed within the scope of customer projects
- Issues and reviews document change requests
- Maintain expertise in current and emerging GxP requirements and quality trends
- Experience in Computer System Validation, GxP regulations and System Development Life Cycle (SDLC)
- LIMS/ELN, Quality Assurance and CLIA experience preferable but not essential
- Extensive understanding and application of validation principles, concepts, practices, and standards
- Very good analytical thinking, problem solving and communication skills
- Bachelor's degree in Life Sciences, Engineering, or related field with a minimum of 3-5 years of validation experience in the Life Sciences industry
Sapio offers a competitive salary as well as an incentive bonus plus medical, vision, dental and 401K with matching retirement benefits.
Please submit resumes to Claude Hatfield, Chatfield@sapiosciences.com.