Veeva Configuration Specialist

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.  

About The Team 

The Information Technology (IT) department plays a critical role in ensuring the smooth and efficient operation of all technology-related systems within the company. They are responsible for managing and maintaining the company's digital infrastructure, including servers, data centers, and cloud computing platforms. They are responsible for providing technical assistance, troubleshooting issues, and resolving problems related to hardware, software, and network connectivity. The department also ensures data security and privacy by implementing robust cybersecurity measures and protocols.

 

About The Role

The Veeva Configuration Specialist is responsible for the maintenance, continuous improvements, and troubleshooting of Forge’s Quality Management System, Veeva Vault. The Veeva Vault Quality system includes QualityDocs, Training, QMS, QRM, LIMS, and other modules that may be implemented in the future. This position will support configuration of Veeva Vault Quality and Platform, as well as supporting any future module implementations. This position must work in cross‑functional groups including Veeva business administrators, business owners, and technical managers. The position will support change control and validation of Veeva Vault Quality.

 

What You'll Do

• Responsible for the management and continuous improvement of the Veeva Vault Platform and all modules within the Veeva Vault Quality Suite.
• Responsible for designing and implementing configurations within Veeva Vault for new business requirements, proposed changes, and identify and implement necessary configurations changes to address workflow issues.
• Responsible for working with Computer Systems Validation SME to validate changes per GAMP 5 guideline and current Good Manufacturing (cGMP) regulations to maintain validation state and compliance.
• Support Veeva Releases and other changes through Change Controls as the system expert.
• Must be a strong communicator and highly organized to work with multiple cross-functional teams to support the continuous improvement of Veeva Vault across multiple modules at one time. 
• Train, support and advise Veeva end users on EDMS and QMS system requirements and workflows. Develop training modules for EDMS and QMS.
• Responsible for writing SOPs and Work Instructions, assists other departments with the generation, review and approval and maintenance of such documents.
• Provide support during regulatory inspections and internal audits.

What You'll Bring

• BS Degree in Computer Science, Information Management Systems, Engineering, Science or in a related field required or equivalent work experience.
• Veeva Vault Platform White Belt Certification is preferred, however other accredited Veeva certification, or equivalent experience may be accepted. 
• A minimum of 3 years of experience with Veeva Vault Platform configuration is required, familiarity with Veeva Vault Quality is preferred. 
• Experience with the implementation, validation, and maintenance of a Computer System in an regulated industry (FDA or equivalent) is preferred.

 

Work Environment and Physical Demands  

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able