CSV Engineer I

Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of  H.O.P.E.  We are  hardworking , showing up each day with determination and grit. We are  open , creating a space where ideas flow freely, and every voice is valued. We are  purpose-driven , with every task directly tied to changing lives. And we are  engaged , energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us. If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. About The Role:  The CSV Engineer I is responsible for ensuring that GxP computerized systems at Forge Biologics are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys BMS. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness. 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. Supports 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 validated state. Qualifications: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field (or equivelant experience). 2+ years of experience in Computer System Validation (CSV) with