Systems Engineer

We are seeking an experienced Systems Engineer to provide technical support for manufacturing applications, IT infrastructure, and Quality Control (QC) laboratory systems within a regulated pharmaceutical manufacturing environment. The ideal candidate will have experience in systems support, troubleshooting, system configuration, GMP compliance, and Computer System Validation (CSV). This role involves collaborating with Manufacturing, Quality, Laboratory Operations, Process Automation, and IT teams to maintain reliable systems, support system implementations, and improve operational efficiency., * Provide technical support for business applications, QC laboratory systems, and manufacturing interfaces.

• Troubleshoot system issues, investigate root causes, resolve incidents, and escalate complex problems when necessary.
• Support servers, network connectivity, user access, permissions, and system configurations.
• Assist laboratory personnel with instrument-related issues, applications, and software integrations.
• Gather business requirements and translate them into technical specifications, workflows, and system documentation.
• Develop and maintain SOPs, work instructions, technical procedures, and system-lifecycle documentation.
• Support system design, configuration, testing, qualification, implementation, and change control.
• Assist with Computer System Validation (CSV), GMP compliance, and data integrity activities.
• Collaborate with internal teams, system owners, vendors, and global IT to maintain system performance and availability.
• Develop Power BI dashboards and reports to monitor plant operations, system performance, and process metrics.
• Support system integrations involving APIs, databases, ETL processes, and process historians.
• Identify opportunities to improve system reliability, standardization, automation, and efficiency.
• Prepare training materials and support end users during system upgrades and implementations.
• Follow applicable cybersecurity, safety, GMP, data integrity, and IT policies.

• 3+ years of experience in systems engineering, application support, infrastructure support, or technical analysis.
• 2+ years of experience supporting pharmaceutical or GMP-regulated manufacturing environments.
• Strong troubleshooting, incident management, and system configuration skills.
• Knowledge of GMP, data integrity, change control, and Computer System Validation.
• Experience gathering requirements and preparing technical specifications, SOPs, and system documentation.
• Familiarity with servers, networking, user access management, and system integrations.
• Exposure to QC laboratory systems, LIMS, MES, DeltaV, SCADA, or similar manufacturing platforms.
• Familiarity with APIs, databases, ETL processes, and data historians.
• Experience with Power BI, Jira, or similar reporting and project management tools.
• Strong analytical, communication, documentation, and cross-functional collaboration skills.
• Must be authorized to work in the United States without employer sponsorship.