Associate GxP Systems Engineer

2 days ago

Norwood, Massachusetts, United States Moderna Full time
About the Role

Moderna is seeking a highly skilled Associate GxP Systems Engineer to join our team. As a key member of our GxP Systems team, you will play a critical role in supporting the validation, delivery, and administration of our laboratory benchtop computerized systems and Enterprise systems.

Key Responsibilities
  • Assist in troubleshooting issues with systems, update configuration, and assist with deployment of systems.
  • Participate in generating and maintaining necessary supporting applications, documents, and procedures.
  • Author and execute test protocols.
  • Drive system validation activities in conjunction with Business, IT, Equipment, Validation, and QA partners.
  • Review and approve lifecycle documents, such as impact assessments, regulatory applicability, and criticality assessments.
  • Provide support to the QC labs for the Benchtop and Enterprise computer systems as a system administrator.
  • Be the first point of contact with Business and help resolve incident tickets.
  • Fulfill access requests for Enterprise computer systems.
  • Assist with incidents requiring troubleshooting and be the subject matter expert to investigate, troubleshoot, find resolution, and implement the resolution.
  • Generate Periodic Reviews for the systems and assist in periodic reviews performed by other SMEs.
Requirements
  • Bachelor's degree in STEM or another relevant academic discipline.
  • A minimum of 6 years with a MS degree, or 8+ with a bachelor's degree; a combination of education and experience may be considered.
  • Experience authoring and reviewing computer system validation lifecycle documents.
  • Prior experience in working in a controlled cGxP environment.
  • Experience with Document Management, QMS, ServiceNow, and System Administration activities.
  • Experience authoring and executing validation lifecycle deliverables.
  • Experience writing change controls and deviations/CAPAs utilizing GxP workflows.
Preferred Qualifications
  • Experience with Benchtop lab computerized systems like TOC, Bioanalyzers, Spectramax/Softmax, etc.
  • Experience with Enterprise Instrumentation Systems such as Chromeleon Chromatography Data System, Mettler LabX, etc.
  • Experience working in life sciences, pharma/biotech, or high-tech industries with a preference for experience in one or more of eCommerce, data/machine learning platforms, or cloud infrastructure.
  • Experience in a regulated environment.
  • Experience working in a matrixed organization.
  • Experience working in a fast-paced environment requiring quality contribution on multiple critical projects.
  • Demonstrated ability to work independently and collaboratively in cross-functional teams and open to learn and adapt to changing demands.
  • Strong communication skills (verbal and written).
About Moderna

Moderna is a leading mRNA technology platform company that is committed to changing the future of medicine. We believe in giving our people a platform to change medicine and an opportunity to change the world.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.

Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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