CSV Engineer I

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 equivalent experience). 2+ 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 (BMS) like Metasys. Strong technical writing skills and ability to execute protocols with minimal supervision. Ability to work onsite (in Columbus, Ohio) 3‑4 days/week on average. Preferred Skills Experience with Veeva Vault platform (QMS or QualityDocs) and BMRAM configuration or validation. Hands‑on validation of laboratory instruments (e.g., HPLC, UV‑Vis,) including software like Empower or Chromeleon. Familiarity with Metasys BMS or similar environmental monitoring systems in a GxP facility. Experience with electronic execution systems such as Veeva Vault Manager or similar. Experience supporting regulatory inspections (FDA, EMA) and responding to CSV‑related observations. Work Environment and Physical Demands This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Health from day one Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family. Time to recharge A competitive paid time off plan – because rest fuels innovation. 12 weeks of fully paid parental leave so you can focus on family when it matters most. Rewarding your impact Annual bonus opportunities for all full‑time team members. 401(k) with company match to help you plan for the future. Special employee discounts, including childcare and dependent care savings. Onsite fitness facility at The Hearth. Mental health counseling and financial planning services through our Employee Assistance Program. Employer‑paid short and long‑term disability coverage to protect your peace of mind. Fuel for your workday A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next. Grow with us Ongoing professional development resources, training, and mentorship programs to help you build your career and grow within Forge. #J-18808-Ljbffr