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
Job description provided by Cognizant Technology Solutions.
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