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

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 and accuracy 
• PAT integration testing
• Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.

Required Qualifications

• Bachelor’s degree in engineering, computer science, or related field.
• Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
• Proven experience with equipment‑level PLC/HMI validation (OEM systems) and historian connectivity.
• Hands‑on experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
• Must be local in or around RTP, must be able to work on site 100%.