6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

<div class="content-intro"><p><span style="font-size: 12pt;"><strong>Description</strong></span></p> <p><strong>Verista’s</strong> 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.</p> <p>Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.</p> <p><strong>Company Culture Guidelines &amp; Values:</strong></p> <ul> <li>We empower and support our colleagues</li> <li>We commit to client success at every turn</li> <li>We have the courage to do the right thing</li> <li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li> <li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li> </ul></div><p><strong>Position Summary</strong></p> <p>The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team.</p> <p><strong>General CSV Skills</strong></p> <ul> <li>Familiarity with global standards for computerized systems and data integrity.</li> <li>Ability to classify systems as “simple” or “complex” using risk‑based criteria to right‑size validation effort.</li> <li>Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.</li> <li>Supplier assessment execution for OEM‑provided computerized systems.</li> <li>Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival.</li> </ul> <p><strong>Project‑Specific CSV Responsibilities</strong></p> <p><strong>CSV Deliverables </strong></p> <ul> <li>Author&nbsp;Data Integrity Assessments&nbsp;for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records h