Process-CSV/Syncade Engineer

Job Summary

Process-CSV/Syncade Engineer - The Process-CSV/Syncade Engineer supports the design implementation validation and lifecycle management of Syncade MES (Manufacturing Execution System) and related computerized systems in a GxP-regulated life science manufacturing environment. The role ensures electronic batch records recipes and system integrations meet data integrity 21 CFR Part 11 and GAMP 5 requirements while improving process efficiency and compliance.

Responsibilities

• Design configure and maintain Syncade electronic batch records (EBRs) master recipes and work instructions in line with ISA-88/ISA-95 standards
• Support integration of Syncade with DeltaV ERP (e.g. SAP) LIMS and historians
• Prepare and execute CSV deliverables per GAMP 5 including validation plans URS FS/DS risk assessments IQ/OQ/PQ and traceability matrices
• Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements
• Author and manage change controls deviations CAPAs and impact assessments to keep systems in a validated state
• Provide L2/L3 production support troubleshoot issues and manage user roles security and master data
• Collaborate with Manufacturing Automation IT and QA on requirements gathering new product introductions and tech transfers
• Maintain SOPs and validation documentation and support periodic reviews audits and regulatory inspections
• Train operations users and drive continuous improvement of EBR design to reduce review-by-exception cycle times