Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a Sr. Computer Systems Validation (CSV) Engineer who is responsible for ensuring compliance to GxP computer system validation and 21 CFR Part 11, and authoring related documentation such as policies, procedures, risk assessments, validation plans, URS, FRS, RTM, validation protocols and validation summary reports.
- Authoring and reviewing Validation deliverables: Validation Risk Assessment, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), validation test scripts, Validation Protocols (Installation Qualification/IQ, Operation Qualification/OQ, and Performance Qualification/PQ), UAT (User Acceptance Test), Requirement Trace Matrix (RTM) and Validation Report.
- Support and oversee validation test execution
- Develop and maintain CSV and Part 11 policies, procedures and templates
- Solid experience in performing validation of COTS and custom/in-house developed applications such as LIMS (Laboratory Information Management System), MDDS (Medical Device Data System), enterprise systems (CRM, ERP), eQMS (Quality Management System/Doc Control System e.g. eTQ), SDLC Tools (JIRA, JAMA, Confluence, GitHub), process software, spreadsheets etc
- Lead risk assessments to determine testing strategies
- Participate in change management process as validation lead
- Strong experience with planning and executing computer systems validation activities
- Support Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during regulatory and customer audits
- Perform other related duties and responsibilities as assigned.
- BS in a Computer Science or Engineering field or equivalent experience
- 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
- 5+ years experience in Computer System Validation (CSV), and 21 CFR Part 11 Electronic Records and Electronic Signatures
- Experience with industry standards and best practices for CSV such as Design Controls and GAMP 5
- Experience working with software development lifecycle (SDLC) processes, and agile/scrum methodologies
- Knowledge of quality system principles, practices, and standards for the life science industry
- Experience with SDLC tools such as Atlassian Suite (JIRA, Confluence, Zephyr etc), JAMA, Github and Jenkins.
- Excellent organizational, interpersonal, verbal and written communication skills
- Able to evaluate situations, apply critical thinking skills, and propose potential solutions
- Ability to deliver quality outputs under minimal supervision.