Associate GxP IT Engineer

Role Summary

Associate GxP IT Engineer responsible for hands-on technical support for endpoints, laboratory instruments, and connected devices in GxP-regulated environments. Focus on reliability, compliance, and cybersecurity of IT systems supporting manufacturing and laboratory operations.

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‚Äîfrom deployment to decommissioning.
• Collaborate with Digital Core, Cybersecurity, and Quality teams to maintain compliance with 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.

Qualifications

• Required: Bachelor‚Äôs degree in Computer Science, Information Technology, Engineering, or a related field‚Äîor equivalent relevant experience.
• Required: 3+ years of hands-on experience supporting GxP IT systems, laboratory instruments, or manufacturing technology in a regulated environment.
• Required: Solid understanding of GxP principles, computerized system validation (IQ/OQ/PQ), and regulated documentation practices.
• Required: Proven ability to follow and maintain SOPs, work instructions, and controlled documentation.
• Required: Experience supporting or integrating systems such as MES (Syncade), DeltaV, OSI PI, BMS, LIMS, and ThinManager.
• Required: Strong technical skills supporting and securing Windows endpoints and instrument-connected PCs.
• Required: Familiarity with cybersecurity controls, endpoint protection platforms, access management, and vulnerability remediation.
• Required: Working knowledge of ITSM processes (incident, change, and problem management) and experience in audit-ready environments.
• Required: Excellent communication, documentation, and organizational skills, with a focus on consistency, accountability, and security-conscious execution.
• Required: Authorization to work in the US without future sponsorship.
• Preferred: Process-oriented and methodical approach with strong analytical and troubleshooting skills.
• Preferred: Ability to collaborate with IT, Automation, Manufacturing, Quality, and Cybersecurity teams; ownership mindset; adaptability; cross-functional collaboration.

Skills

• GxP IT systems
• Endpoint and instrument-PC security
• System integration (MES, DeltaV, OSI PI, BMS, LIMS)
• ITSM and IT governance
• Documentation and SOP development

Education

• Bachelor‚Äôs degree in Computer Science, Information Technology, Engineering, or related field (or equivalent experience).