Associate GxP IT Engineer jobs in United States
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Moderna · 1 week ago

Associate GxP IT Engineer

Moderna is a leading mRNA technology company dedicated to transforming medicine. They are seeking an Associate GxP IT Engineer to provide technical support for IT systems in regulated environments, ensuring compliance and cybersecurity across their manufacturing and laboratory operations.

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
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), DeltaV, OSI PI, BMS, ThinManager, 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

Qualification

GxP IT systemsComputerized system validationWindows endpoint supportMES (Syncade)Cybersecurity controlsIT Service ManagementAnalytical skillsTroubleshooting skillsCommunication skillsOrganizational skills

Required

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), DeltaV, OSI PI, BMS, LIMS, and ThinManager
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
Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship

Preferred

Process-oriented and methodical approach with strong analytical and troubleshooting skills
Demonstrated ability to maintain precision and discipline under pressure while supporting critical operations
Commitment to following validated procedures, maintaining secure configurations, and documenting activities thoroughly
Ability to collaborate effectively with IT, Automation, Manufacturing, Quality, and Cybersecurity teams
Strong sense of ownership, accountability, and dedication to maintaining a secure and compliant digital environment
Adaptable, organized, and consistent in managing multiple priorities while upholding high standards of security and compliance
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