Advanced IT-OT Operation & Infrastructure Professional

Job Title: Advanced IT-OT Operation & Infrastructure Professional

Location: Boulder, CO (5 days onsite)

Duration: 12 Months with Possible Extension

Must Have Skills:

- Experience with GMP and/or GxP manufacturing technology

- Experience in managing IT-OT setup for labs and production facilities

- Once onboarded, must learn the compliance requirements and implement them

- Basic understanding of IT network and security

- Demonstrates high subject matter knowledge in IT/OT operations and infrastructure.

- Sets directions and delivers results that impact the unit or organization.

- Provides technical support and contributes through expertise and knowledge application.

- Handles complex tasks with few or no defined procedures.

- Solves problems by choosing between known alternatives within the area of expertise.

- Operates, maintains, and builds infrastructure.

- Installs, configures, and maintains IT/OT systems software and hardware.

- Collaborates effectively with colleagues at Boulder site and globally.

- Evaluates the appropriateness and effectiveness of solutions with minimal guidance.

- Bachelor's degree and 4+ years of experience.

- Knowledge or experience working with GMP systems or equipment is required, especially 21 CFR Part 11 compliance requirements”

-Knowledge or experience working with PLCs and industrial automation is required.

PURPOSE

As an Advanced/OT Operation & Infrastructure Professional, you will serve as the first point of contact for the Boulder site regarding any IT equipment or IT system related issues. You will collaborate with suppliers and global teams to resolve these issues efficiently. Additionally, you will be responsible for managing IT-related compliance needs and documentation for projects, ensuring all requirements are met and maintained.

ESSENTIAL FUNCTIONS

1. Manage and Maintain IT/OT Infrastructure for both labs and GxP manufacturing equipment.

- Oversee the installation, configuration, and maintenance of IT systems software and hardware for multi-user server computers and personal computing devices.

- Ensure the operational integrity and performance of infrastructure, providing backup and monitoring services.

- Automate routine tasks using scripting to enhance efficiency and reduce manual intervention.

- Troubleshoot and resolve complex issues with minimal guidance, ensuring continuity of service.

- Serve as the first point of contact for all IT-related issues, working with global teams and suppliers in the US.

- Cover computerized equipment and systems in analytical labs and manufacturing environments.

-Support industrial automation infrastructure, including trouble shooting field devices and networked systems.

2. Provide Technical Support and Expertise for both labs and manufacturing part of GMP plant

- Deliver expert technical support for defined issues, applying subject matter knowledge to resolve problems effectively.

- Evaluate and implement known alternatives to address complex system software configurations and enhancements.

- Document and communicate solutions and best practices to enhance team knowledge and efficiency.

3. Ensure Compliance and Security for both labs and manufacturing part of GMP plant

- Implement and maintain security protocols to protect IT infrastructure and data integrity.

- Conduct regular assessments to ensure compliance with organizational and regulatory standards.

- Support development and maintenance of documentation for IT processes, procedures, and configurations.

- Collaborate with security teams to address vulnerabilities and enhance system security measures.

- Work with system managers in global teams during audits.

QUALIFICATIONS

Minimum Qualification

Bachelor's Degree from an accredited university or equivalent education with 3+ years of experience required.