Essential Duties and Responsibilities:- Administer, monitor, and maintain GxP-relevant systems used in manufacturing, engineering, and quality operations.
- Perform basic network troubleshooting, including verifying IP addresses, connectivity checks, and device communication.
- Support and maintain SQL databases, including running queries, performing basic data extraction, and assisting with system integrations.
- Interface with Active Directory to retrieve user access reports, validate permissions, and support account-related workflows.
- Assist with configuration and security hardening of Operational Technology (OT) devices, including HMIs, PLCs, data historians, and other automation-related systems.
- Maintain system documentation, user access logs, and change records in accordance with GxP and data integrity requirements.
- Support quality system processes, including deviations, CAPAs, change controls, and periodic reviews.
- Manage small-scale projects such as system upgrades, patching cycles, or equipment integrations, ensuring alignment with engineering, quality, and operations.
- Collaborate with cross-functional teams to troubleshoot issues, improve system reliability, and support continuous improvement initiatives.
- Learn, adopt, and help administer quality management systems (QMS) and other regulated platforms.
Qualifications: - High school diploma or equivalent (GED) required.
- Bachelor's degree preferred in Engineering (Mechanical, Electrical, Chemical, or similar), Computer Science / Information Technology, Pharmaceutical Sciences, Automation / Industrial Technology
- 2-3 years' experience working in a GxP-regulated pharmaceutical, biotech, or medical device environment.
- Strong computer proficiency, including:
- Checking and validating IP addresses, device connectivity, and basic network diagnostics.
- Hands-on experience with SQL databases (queries, data extraction, basic troubleshooting).
- Familiarity with Active Directory (user lookups, group membership, access reporting).
- Basic understanding of Operational Technology (OT) systems and cybersecurity principles for industrial devices.
- Ability to work independently, prioritize tasks, and solve problems with minimal supervision.
- Strong documentation skills and attention to detail.
- Ability to learn and manage quality systems and quality events.
- Demonstrated ability to manage small projects and coordinate with multiple departments.
- Experience supporting automation or engineering systems (e.g., SCADA, MES, LIMS, historians).
- Understanding of data integrity principles (ALCOA+).
- Familiarity with validation processes (IQ/OQ/PQ) and change control.
- Experience in a manufacturing or engineering support role.
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