E-System Engineer

Job Summary

E - System Engineer - The E-System Engineer supports the implementation maintenance and lifecycle management of electronic systems (e.g. MES LIMS QMS DMS ERP and historians) in a GxP-regulated life science manufacturing environment. The role ensures systems are validated secure and compliant with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements while providing reliable technical support and driving continuous improvement.

Responsibilities

• Configure administer and maintain GxP electronic systems such as MES LIMS QMS document management and ERP-related applications
• Provide L2/L3 technical support troubleshoot incidents and perform root cause analysis to minimize downtime
• Prepare and execute CSV deliverables per GAMP 5 including validation plans URS risk assessments IQ/OQ/PQ and traceability matrices
• Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity requirements including audit trails and electronic signatures
• Manage user access roles security and master data in line with defined SOPs and periodic review requirements
• Author and manage change controls deviations CAPAs and impact assessments to keep systems in a validated state
• Support system integrations and interfaces between shop-floor laboratory and enterprise systems
• Plan and support system upgrades patches migrations backups and disaster recovery testing
• Collaborate with Manufacturing QA IT and Automation teams to gather requirements and support new projects and tech transfers
• Maintain SOPs and system documentation train end users and support audits and regulatory inspections