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Forge Biologics

End-to-end manufacturing of AAV gene therapies

Veeva IT Systems Analyst 2

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeColumbus, OH, USANo salary listed

About the Job

Requirements

  • A Bachelor of Science degree in Computer Science, Information Management Systems, Engineering, Life Sciences, or a related field, or equivalent work experience.
  • At least 3 years of experience configuring the Veeva Vault Platform.
  • Strong communication and organizational skills, with the ability to manage multiple priorities and stakeholders simultaneously.
  • Demonstrated experience supporting cross-functional teams in a matrixed organization.
  • Ability to translate complex technical system requirements into practical guidance for non-technical end users.

Responsibilities

  • Manage and continuously improve the Veeva Vault Platform and all modules within the Veeva Vault Quality Suite.
  • Design and implement Veeva Vault configurations for new business requirements and proposed changes, and identify and implement configuration changes needed to address workflow issues.
  • Work with the Computer Systems Validation subject matter expert to validate changes according to GAMP 5 guidelines and current Good Manufacturing Practice regulations, maintaining the system’s validated state and compliance.
  • Support Veeva releases and other changes through change controls as the system expert.
  • Communicate and organize work with multiple cross-functional teams to support continuous improvement of Veeva Vault across multiple modules simultaneously.
  • Train, support, and advise Veeva end users on electronic document management system and quality management system requirements and workflows.
  • Develop training modules for electronic document management and quality management systems.
  • Write standard operating procedures and work instructions, and liaise with other departments on their generation, review, approval, and maintenance.
  • Provide support during regulatory inspections and internal audits.

Desired Qualifications

  • Familiarity with Veeva Vault Quality modules, including QualityDocs, Training, QMS, QRM, and LIMS.
  • Veeva Vault Platform White Belt Certification or another accredited Veeva certification.
  • Experience implementing, validating, and maintaining a computer system in a regulated industry such as FDA-regulated, biotechnology, or pharmaceutical environments.
  • Project management experience.
  • GAMP 5, ITIL, or other IT best-practice training or certification.

About the Company

Forge Biologics

End-to-end manufacturing of AAV gene therapies

Forge Biologics provides end-to-end development and manufacturing for gene therapies, using its proprietary engine to translate concepts from the lab to GMP production. It focuses on AAV gene therapies and operates from Hearth, a large cGMP facility built for scalable manufacturing. Revenue comes from offering manufacturing services to other companies and researchers, while it also pursues its own gene therapy programs. Its goal is to be a leading, integrated manufacturing partner in the gene therapy field and to advance its own therapies for rare genetic diseases.

Company size
201-500
Company stage
Acquired
Total funding
$250M
Headquarters
Columbus, OH
Founded
2020

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