IT/OT Infrastructure Engineer - GMP Manufacturing & GxP Systems
Job Description
Title: IT/OT Infrastructure Engineer – GMP Manufacturing & GxP Systems
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Location: Boulder, CO (Onsite, Monday–Friday)
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Employment Type: Contract – 1 Year
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Status: Accepting Candidates
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About the Role
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Seeking an experienced IT/OT Infrastructure Professional to support IT systems, laboratory equipment, and GxP manufacturing infrastructure. The role focuses on maintaining system reliability, troubleshooting technical issues, and ensuring GMP/GxP compliance across laboratory and manufacturing environments.
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Key Responsibilities
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- Manage and maintain IT/OT infrastructure supporting laboratories and GxP manufacturing equipment.
- Install, configure, maintain, and troubleshoot IT hardware, software, servers, and computing devices.
- Provide technical support for computerized systems and equipment in analytical laboratories and manufacturing environments.
- Support industrial automation infrastructure, including field devices and networked systems.
- Maintain 21 CFR Part 11 compliance, security protocols, and data integrity requirements.
- Collaborate with global teams and suppliers to resolve technical issues and support audits.
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Qualifications
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- Bachelor's degree from an accredited university with 3+ years of experience.
- Experience with GMP/GxP manufacturing technology or regulated manufacturing systems.
- Experience managing IT/OT infrastructure for laboratories and production facilities.
- Knowledge of 21 CFR Part 11 compliance and GMP systems or equipment.
- Basic understanding of IT networking and security.
- Knowledge of PLCs and industrial automation is preferred.
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