IT/OT Infrastructure Lead – GMP & GxP Compliance

Artech; Boulder (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

Artech is seeking an Advanced IT-OT Operation & Infrastructure Professional for our Boulder, CO site. This role focuses on managing IT/OT infrastructure for labs and GMP manufacturing equipment, ensuring compliance with 21 CFR Part 11, and coordinating with global teams.

Primary responsibilities include installation and maintenance of IT/OT systems, security, and automation support. The position requires a Bachelor’s degree with 3+ years of experience and is 5 days onsite in Boulder.

Qualifications

• Experience with GMP/GxP manufacturing technology.
• Experience in managing IT-OT setup for labs and production facilities.
• Onboarded staff to learn and implement compliance requirements.
• Basic understanding of IT network and security.
• High subject matter knowledge in IT/OT operations and infrastructure.
• Ability to set directions and deliver results.
• Provides technical support and applies expertise to problems.
• Handles complex tasks with minimal procedures.
• Solves problems by selecting between known options in their domain.
• Operates, maintains, and builds IT/OT infrastructure.
• Installs, configures, and maintains IT/OT systems software and hardware.
• Collaborates with Boulder site and global colleagues.
• Assesses solution adequacy with minimal guidance.
• Bachelor's degree plus 3+ years experience.
• Experience with GMP systems or equipment, especially 21 CFR Part 11 compliance.
• Knowledge of PLCs and industrial automation.

Responsibilities

• Manage and maintain IT/OT infrastructure for labs and GMP equipment.
• Oversee installation, configuration, and maintenance of IT systems for servers and devices.
• Ensure infrastructure reliability with backup and monitoring services.
• Automate routine tasks with scripting to improve efficiency.
• Troubleshoot and resolve complex issues with minimal guidance.
• Be the first point of contact for IT issues with global teams and suppliers in the US.
• Support analytical labs and manufacturing environments.
• Assist with industrial automation infrastructure and networked systems.
• Provide expert technical support for defined issues and document best practices.
• Ensure compliance and security for GMP plant IT systems.
• Collaborate with security teams during audits.
• Develop and maintain IT process documentation.

Skills

GMP/GxP knowledge

IT/OT infrastructure

IT network security basics

Industrial automation experience

21 CFR Part 11 compliance

Troubleshooting complex issues

Server & IT administration

Education

Bachelor's degree

Job description

Artech is seeking an Advanced IT-OT Operation & Infrastructure Professional for our Boulder, CO site. This role focuses on managing IT/OT infrastructure for labs and GMP manufacturing equipment, ensuring compliance with 21 CFR Part 11, and coordinating with global teams.

Primary responsibilities include installation and maintenance of IT/OT systems, security, and automation support. The position requires a Bachelor’s degree with 3+ years of experience and is 5 days onsite in Boulder.