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