GxP Quality Systems Engineer
Location: Norwood, Massachusetts
Reporting to the Associate Director, Quality Systems, the GxP Quality Systems Engineer will serve as a support of the technical design, development, delivery and maintenance of the GxP Compliance Systems - Quality Management, Document Management, Validation System Management. This position will play a key role in maintaining systems and the integrated processes to support the overall digital / IT QA compliance systems landscape at Moderna.
- System administrator support for the day-to-day administration of Veeva Quality Vault and Kneat Validation Management System.
- Monitor help desk requests and incidents to troubleshoot critical production issues impacting end-users, including system lifecycles, workflows, security settings and object issues.
- Work directly with the SaaS support teams to bring open service issues to a resolution by triage and monitoring progress.
- Support issue resolution, continuous process improvements and routine system updates of Veeva Quality Vaults and other compliance systems.
- Consult with the compliance business areas on development and managed deployment of system enhancements to ensure efficient usage and maintenance of technology.
- Ensure current system functionality is maintained and assess impact and integrity of introducing new functionality into systems.
- Support requirement definition and provide technical design insight within the applications and integrations between compliance systems other GxP systems (ERP, LIMS and MES) and Partner Systems.
- Create and maintain GxP computer system deliverables including user requirements, system specifications and validation test scripts.
- Perform system sandbox testing and participate in formal system validation testing execution.
- Assist in system assessments quarterly or yearly to support vendor software releases and patches.
- Report and management any issues/bugs in the applications to Vendors and assist in troubleshooting and testing.
- Provide support for planned and unplanned inspections/audits.
- A bachelor’s degree in science, technology or another relevant academic discipline.
- 5-8 years of experience implementing and maintaining technology to support GxP QS processes.
- Excellent interpersonal and communication skills with ability to work collaboratively within a team of stakeholders and influence decisions.
- Must have a customer service mindset.
- Quality orientated with strong attention toward details.
- Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
- Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction.
- Understanding of industry technology trends in quality management, document management and learning management.
- Experience with Veeva Vaults (eTMF, Quality (Docs and eQMS). Experience with SAP SuccessFactors learning management, Please Review and Validation Management System (Kneat) is a plus.
- Understanding of roles and security required when developing or customizing objects.
- Expertise with computer systems validation practices (GAMP).
- API, data report development and systems integration.
- Technical writing skills required.
- Capable of operating within a fast-moving business environment