LIMS System & Data Specialist II

forgebiologics

📍 Columbus, Ohio
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Job Description

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 LIMS System & Data Specialist II role will be the primary business user for the Veeva Laboratory Information Management System (LIMS) within the Quality Control (QC) group. This role is responsible for building and maintaining test definitions, sample plans, specification requirements and study designs in LIMS to support in-process, release, and stability testing for AAV, plasmid, cell bank, buffer, and raw materials, along with generation of electronic Certificate of Analysis (COA) and Certificate of Testing (COT) documents needed to support batch release or disposition. Acting as a Tier 1 LIMS support resource, this role partners closely with QC subject matter experts, QA, IT, and the LIMS System Administrator to support compliant system use, continuous improvement, and adoption of new LIMS functionality. This position plays a critical role in maintaining data integrity, operational readiness, and inspection preparedness in support of client gene therapy programs. Responsibilities: Provide Tier 1 LIMS support Build and maintain test definitions, sampling plans, specifications, and stability protocols in Veeva LIMS, in collaboration with QC SMEs. Configure and issue Certificates of Analysis (COA) and Certificates of Testing (COT) in support of batch release and disposition. Support routine troubleshooting of data-related issues and escalate technical problems to System Admin or vendor as needed. Work with System Administrator to develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems. Work closely with IT, QA, and Q

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