Computer System Validation (CSV) Engineer--Epic Implementation

Interview mode: Video Authorized to work on projects across the USA with flexibility for relocation as required. • Hybrid model • 3 days onsite - 8000 Marina Blvd, Suite 4 Brisbane, CA 94005 • Candidate will be: • Embedded with project team members • QA leadership is based in Brisbane • Primary onsite location: Marina office Project Overview • CareDx has implemented Epic and is currently progressing through a phased rollout (Wave approach). • Epic is becoming the system of record / source of truth. • Wave 1 • Focused on data migration • Migrating data from LIMS to Epic • Real‑time data movement • Wave 2 • Reporting • Additional application implementations • Customer engagement tools • CLS appointment application • Multiple integrations between lab systems and other applications • Examples mentioned: Middleware / lab integration tools, HelloCat (note: candidate familiarity with lab integrations is key) Detailed JD What They’re Looking For • Strong CSV / QA oversight for Epic implementation and data migration activities • Ideal background: • LIMS or LIS experience • Epic experience is preferred, but not mandatory • Understanding of data flows, interfaces, and integration testing • Someone who can: • Provide regulatory guidance • Advise teams on validation best practices • Define the best compliance path forward • Candidates should be comfortable acting as a QA gatekeeper, not just document reviewers Team & Environment • QA organization: • ~6 dedicated QA team members • ~60 people total across programs • 8–9 core teams, plus multiple sub‑teams • Many team members are new to Epic and CSV processes • Working in an Agile methodology • This role will: • Engage across all teams • Ensure consistency and harmony across validation documentation • Guide teams on how to document properly • Set examples of good QA and validation practices Key Soft Skills • Strong communication • Ability to explain “what the process dictates and why” • Confidence working cross‑functionally with IT, labs, PMO, and vendors Timing & Interview Process • Hiring manager will be out next week but still able to review. Plan is to schedule interviews the following week so week of 3/30 • Target to resume/advance interviews starting March 30 • Interview structure: • QA Manager • Senior QA / SQA leader Full JD QA Computer System Validation (CSV) Engineer – Epic Implementation Position Summary The QA Computer System Validation (CSV) Engineer will support the Epic implementation by ensuring that Epic modules, interfaces, and integrated systems are validated, compliant, and fit for intended use in accordance with CLIA, CAP, FDA and internal Quality Management System (QMS) requirements. This role partners closely with IT, CLIA Lab, Customer engagement team, and vendors to ensure patient safety, data integrity, and regulatory readiness throughout the Epic lifecycle. Key Responsibilities • Provide QA oversight for Validation activities for EPIC implementation and Data Migration activities. • Own and enforce the SDLC framework aligned with FDA 21 CFR Part 11, CLIA, CAP and internal quality policies. • Review and approve validation deliverables, to ensure validation activities are risk based, compliant, and inspection ready. including: o Validation Plans o Intended Use and Risk Assessments o Test Plans (Functionality and UAT) o Traceability matrices o Validation Summary Reports • Partner with PMO team to ensure the project deliverables are drafted, reviewed and approved in a timely fashion. • Identify any future risks and provide guidance on to how we can overcome the risk still adhering to project timelines. • Act a gate keeper for the requirements specifications as needed in case of Agile methodology implementation. Preferred Qualifications • 3 - 5+ years of experience in CSV or QA in a regulated environment. • Strong understanding of: o Computer System Validation (CSV) lifecycle o Risk based validation and assurance approaches o IQ / OQ / PQ methodologies • Experience reviewing and approving validation documentation from a QA perspective. • Familiarity with regulated systems and data integrity principles. • Epic certification or formal Epic implementation exposure (nice to have).