LIMS System & Data Specialist II

Forge Biologics • Columbus, OH

1d • Hybrid

About The Position

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.

Requirements

• AS or BS in Life Sciences, Biotechnology, or a related field is preferred, with degrees in Computer Science or a related field (or equivalent professional experience).
• Experience working in a GxP-regulated laboratory environment (biologics, gene therapy, or pharmaceuticals preferred).
• Familiarity with Veeva LIMS or other enterprise LIMS platforms (LabWare, LabVantage, STARLIMS, etc.).
• Experience working in compliance with FDA 21 CFR Part 11, GMP, and data integrity regulations.
• Strong problem-solving and analytical skills with attention to detail.
• Excellent communication and training abilities to support QC personnel.
• Strong collaboration with cross-functional teams (QC, QA, IT, Manufacturing, Regulatory Affairs, and external vendors).
• Ability to work onsite (in Columbus, Ohio) 2-3 days/week on average.

Nice To Haves

• Understanding of QC analytical methods, sample types, and AAV manufacturing processes, or viral vector manufacturing.
• Familiarity with database management, system validation, and software lifecycle management.
• Basic understanding of data governance principles (controlled vocabularies, data dictionaries, master data ownership).
• Exposure to regulatory inspections and providing LIMS-related documentation.
• Prior experience supporting user training or developing SOPs/guides for LIMS users.

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 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.

Benefits

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
• A competitive paid time off plan
• 12 weeks of fully paid parental leave
• Annual bonus opportunities for all full-time team members.
• 401(k) with company match
• 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
• A fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree