CSV Engineer

Roles & Responsibilities

• Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
• Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
• Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
• Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
• Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
• 5+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
• Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
• Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
• Strong technical writing skills and ability to execute protocols with minimal supervision.

Nice to have

• BMRAM and analytical lab instruments experience.