6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Description Verista’s 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. 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. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Position Summary 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. General CSV Skills Familiarity with global standards for computerized systems and data integrity. Ability to classify systems as “simple” or “complex” using risk‑based criteria to right‑size validation effort. Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports. Supplier assessment execution for OEM‑provided computerized systems. Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival. Project‑Specific CSV Responsibilities CSV Deliverables Author Data Integrity Assessments for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records handling. Assess and document how PAT result data integrates with the paper‑based manufacturing batch record (MBR) interface, ensuring data integrity at the point of data transfer. Perform supplier assessments for major OEM systems and PAT instruments. Author configuration specifications for computerized systems where client templates are available or where vendor documentation is insufficient. Write CSV sections within IQ/OQ protocols – access control, audit trail verification, time sync (NTP), backup/restore, and data flow tests. Develop data flow diagrams for critical integrations: Execute IQ/OQ CSV test scripts, including; User role and access control, Audit trail review, Time synchronization, Backup and restore, and Data flow ...