Sr. IT/OT Support Engineer, GxP Manufacturing and Labs jobs in United States
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Moderna · 6 hours ago

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

Moderna is a biotechnology company focused on mRNA technology and healthcare innovation. They are seeking a skilled GxP IT Engineer to provide hands-on technical support for endpoints and laboratory instruments in regulated environments, ensuring compliance and operational integrity.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
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Comp. & Benefits
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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

Qualification

GxP IT systems supportComputerized system validationMES (Syncade) experienceWindows endpoints troubleshootingCybersecurity controls knowledgeIT Service Management (ITSM)Network routingSwitchingCommunication skillsProblem-solving skillsCollaboration skillsDetail-oriented

Required

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

Preferred

Strong analytical and problem-solving skills with a proactive, solution-oriented mindset
Demonstrated ability to remain calm and effective under pressure while supporting critical manufacturing and laboratory operations in a 24x7 environment
Excellent communication and interpersonal skills, with the ability to collaborate across IT, Automation, Engineering, Manufacturing, Quality, and Cybersecurity teams
Highly organized, detail-oriented, and disciplined in following established processes, documentation standards, and compliance requirements
Proven ability to work independently and manage priorities with minimal supervision while maintaining alignment with team goals and service expectations
Adaptable and resourceful—able to navigate change in a dynamic, high-growth, and compliance-driven environment
Strong sense of ownership, accountability, and commitment to delivering high-quality, reliable, and compliant technical support
Collaborative mindset with a focus on partnership, transparency, and continuous improvement within a global, cross-functional team

Benefits

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Company

Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.

Funding

Current Stage
Public Company
Total Funding
$4.56B
Key Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M

Leadership Team

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Stephane Bancel
Founding CEO
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Kenneth Chien
Co-Founder
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Company data provided by crunchbase