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 environments, ensuring reliability, compliance, and cybersecurity of IT systems supporting manufacturing and laboratory operations. Part of the global GxP IT Support team, delivering high-quality service through documented processes and adherence to security standards.

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 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

• Bachelor‚Äôs degree in Computer Science, Information Technology, Engineering, or a related field‚Äîor 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.
• Current work authorization in the US without the need for future sponsorship.

Skills

• Process-driven and collaborative; strong analytical and troubleshooting abilities.
• Ability to maintain precision and discipline under pressure; ownership and accountability for secure, compliant operations.
• Ability to collaborate with IT, Automation, Manufacturing, Quality, and Cybersecurity teams.

Education

• Relevant degree or equivalent experience as listed in Qualifications.