IT/OT Lab Systems Engineer - CSV / GxP Systems
Responsibilities
- Provide Level 3+ IT/OT support for the East Hanover CGTDM site, including site-managed isolated networks.
- Deliver advanced support for GxP and development instrument control systems and analytical applications, including operating system troubleshooting, configuration, and maintenance.
- Support implementation and rollout of major infrastructure and application projects across the site.
- Work closely with Level 1–3 support teams and qualification/validation resources to provide technical guidance, troubleshooting, and issue resolution for instrument systems and operating environments.
- Support IT/OT infrastructure and automation systems within isolated network environments and Windows Active Directory domains.
- Manage configuration control and lifecycle support for analytical and clinical production computerized systems.
- Support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities in accordance with corporate policies, local procedures, and regulatory requirements.
- Serve as Subject Matter Expert (SME) for GxP documentation, including development and updates of qualification protocols, commissioning documents, summary reports, SOPs, and work instructions.
- Conduct dry runs of validation and qualification documentation to ensure accuracy, completeness, and regulatory compliance.
- Act as SME for protocol deviations, root cause analysis, and disaster recovery planning activities. xrczosw
- Support deviations, quality events, and change control processes by providing technical input and documentation to ensure compliance and timely resolution.
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