LIMS System & Data Specialist II

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 ofH.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.

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.

• 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 elevate 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 QC leadership to test system settings, user roles, and permissions.
• Collaborate with laboratory staff to identify system improvements and customize LIMS functionalities.
• Develop SOPs, training materials, and documentation for LIMS system use and best practices.
• Train QC personnel on LIMS functionalities, data entry procedures, and reporting workflows.
• Ensure LIMS operations comply with GMP, FDA 21 CFR Part 11, USP, and data integrity requirements.
• Support internal and external regulatory audits and inspections by providing LIMS documentation and system access as required.
• Collaborate on periodic system reviews and validations to maintain compliance with regulatory standards.
• Work with QC leadership to support ongoing LIMS improvements and upgrades.
• Assist in integrating LIMS with other business systems and instruments.
• Assist with generating routine QC reports and trending data as requested.