Associate GxP IT Engineer
Listed on 2025-12-08
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IT/Tech
Cybersecurity, IT Support
Overview
The Role We are seeking a methodical, detail-oriented Associate GxP IT Engineer to provide hands-on technical support for endpoints, laboratory instruments, and connected devices operating in Moderna’s regulated (GxP) environments. This role is critical to maintaining the reliability, compliance, and cybersecurity of IT systems that support our manufacturing and laboratory operations.
You will be part of the global GxP IT Support team, delivering consistent, high-quality service through disciplined execution of established processes, rigorous documentation, and adherence to security and compliance standards. You will ensure that workstations, analytical instruments, printers, and related systems remain compliant, connected, and protected against cybersecurity threats.
The ideal candidate is organized, pragmatic, and process-driven—someone who values precision, documentation, and security as essential to operational excellence. This position offers an opportunity to contribute directly to Moderna’s mission by strengthening the reliability and compliance of digital systems supporting product development and manufacturing worldwide.
Responsibilities- Provide hands-on technical support for endpoints, laboratory instruments, and connected devices in GxP-regulated manufacturing and lab environments.
- Perform configuration, maintenance, and lifecycle management of GxP endpoints and instrument-connected PCs in accordance with approved SOPs and IT processes.
- Troubleshoot and resolve issues involving systems such as MES (Syncade), Delta
V, OSI PI, BMS, Thin Manager, and Zebra label printers, escalating complex problems as needed. - Partner with automation, lab, and manufacturing teams to ensure systems and instruments are properly installed, qualified, and supported through their lifecycle—from deployment to decommissioning.
- Collaborate with Digital Core, Cybersecurity, and Quality teams to maintain compliance with Moderna’s IT and regulatory standards, including patching, vulnerability remediation, access control, and endpoint protection.
- Participate in incident, problem, and service request management, maintaining complete and audit-ready documentation of activities and outcomes.
- Execute all work under defined change control and validation procedures, ensuring systems remain compliant and secure.
- Contribute to developing and maintaining standard operating procedures, work instructions, and technical documentation to ensure consistent and compliant operations across global sites.
- Identify and recommend improvements that strengthen system reliability, cybersecurity posture, and service efficiency.
- Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field—or equivalent relevant experience.
- 3 or more years of hands-on experience supporting GxP IT systems, laboratory instruments, or manufacturing technology in a pharmaceutical, biotech, or similarly regulated environment.
- Solid understanding of GxP principles, computerized system validation (IQ/OQ/PQ), and regulated documentation practices.
- Proven ability to follow and maintain standard operating procedures, work instructions, and controlled documentation.
- Experience supporting or integrating systems such as MES (Syncade), Delta
V, OSI PI, BMS, LIMS, and Thin Manager. - Strong technical skills supporting and securing Windows endpoints and instrument-connected PCs.
- Familiarity with cybersecurity controls, endpoint protection platforms, access management, and vulnerability remediation.
- Working knowledge of IT Service Management (ITSM) processes (incident, change, and problem management) and experience working in audit-ready environments.
- Excellent communication, documentation, and organizational skills, with a focus on consistency, accountability, and security-conscious execution.
- For this role, candidates must already hold work authorization in the United States and be able to maintain that status without the need for future sponsorship.
- Process-oriented and methodical approach with strong analytical and troubleshooting skills.
- Demonstrated ability to maintain precision and discipline under…
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