Sr. IT/OT Support Engineer, GxP Manufacturing and Labs

Role Summary

Sr. IT/OT Support Engineer, GxP Manufacturing and Labs — Role focused on hands-on technical support for endpoints, laboratory instruments, and connected devices in GxP-regulated environments, ensuring reliability, compliance, and security of IT systems underpinning manufacturing and laboratory operations.

Responsibilities

• Provide hands-on technical support for endpoints, laboratory instruments, and connected devices in GxP-regulated manufacturing and lab environments, ensuring reliable, compliant, and secure operations.
• Support and maintain key systems including MES (Syncade), DeltaV, OSI PI, BMS, ThinManager, and Zebra label printers, ensuring uptime, proper configuration, and integration with related systems.
• 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 ensure all systems meet Moderna’s IT and compliance standards, including patching, access management, and vulnerability remediation.
• Perform troubleshooting, maintenance, and configuration activities on GxP endpoints and instrument-connected PCs, ensuring alignment with established SOPs, ITSM processes, and change control requirements.
• Participate in incident, problem, and service request management activities, maintaining clear documentation, root cause analysis, and audit-ready records.
• Ensure GxP systems and endpoints are managed according to approved lifecycle processes, including system validation (IQ/OQ/PQ), periodic review, and decommissioning.
• Collaborate with vendors and internal stakeholders to resolve complex technical issues and drive continuous improvement in reliability and service delivery.
• Contribute to the development of standard operating procedures, work instructions, and technical documentation to promote consistency and compliance across global sites.
• Participate in cross-functional initiatives to strengthen GxP IT service management, helping to embed security, compliance, and operational excellence into daily support practices.

Qualifications

• Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field—or equivalent relevant experience.
• 7+ years of hands-on experience supporting GxP IT systems, laboratory instruments, or manufacturing technology in a pharmaceutical or biotech environment.
• Strong understanding of GxP principles, computerized system validation (IQ/OQ/PQ), and documentation practices required in regulated settings.
• Experience supporting or integrating systems such as MES (Syncade), DeltaV, OSI PI, BMS, LIMS, and ThinManager, along with laboratory instruments and Zebra printers.
• Proven ability to troubleshoot and support Windows endpoints and instrument-connected PCs, ensuring compliance with corporate security standards.
• Familiarity with Cybersecurity controls and endpoint protection tools (e.g., CrowdStrike or equivalent).
• Experience collaborating with cross-functional teams, including automation, lab engineering, Quality, and Cybersecurity, to deliver reliable and compliant system operations.
• Working knowledge of IT Service Management (ITSM) concepts (incident, change, and problem management) and experience in SOP-driven, audit-ready environments.
• Excellent communication, documentation, and stakeholder engagement skills, with a focus on consistency, accountability, and service excellence.
• Understanding of network routing, switching and firewall concepts.

Skills

• Analytical and problem-solving abilities; proactive, solution-oriented mindset.
• Ability to remain calm and effective under pressure in a 24x7 manufacturing/lab environment.
• Strong collaboration and interpersonal skills across IT, Automation, Engineering, Manufacturing, Quality, and Cybersecurity teams.
• Organized, detail-oriented, and disciplined in following processes, documentation standards, and compliance requirements.
• Ability to work independently, manage priorities, and align with team goals and service expectations.
• Adaptability to navigate change in a dynamic, high-growth, compliance-driven environment.
• ownership, accountability, and commitment to delivering high-quality, reliable, and compliant technical support.
• Collaborative mindset with a focus on partnership and continuous improvement within a global, cross-functional team.

Education

• As listed in Qualifications.