Process-CSV/Syncade Engineer

Cognizant; Limerick; On-site; EUR 65,000 - 95,000; Full time

Job summary

Cognizant seeks a Process-CSV/Syncade Engineer to support the design, implementation, validation and lifecycle management of Syncade MES and related systems in a GxP-regulated life sciences environment.

The role focuses on electronic batch records, master recipes, system integrations and data integrity (21 CFR Part 11) while driving efficiency and compliance across manufacturing operations.

Qualifications

• Experience with Syncade MES implementations in life sciences.
• Familiarity with CSV/URS, FS/DS, validation plans and GAMP 5.
• Understanding of 21 CFR Part 11 and data integrity (ALCOA+).
• Ability to design, configure and validate EBRs and master recipes.

Responsibilities

• Design, configure and maintain Syncade electronic batch records (EBRs) and master recipes per ISA-88/ISA-95.
• Support integration of Syncade with DeltaV ERP (e.g. SAP), LIMS and historians.
• Prepare and execute CSV deliverables per GAMP 5 including IQ/OQ/PQ and traceability matrices.
• Ensure compliance with 21 CFR Part 11, EU Annex 11 and data integrity requirements.
• Author change controls, deviations, CAPAs and impact assessments to keep systems validated.
• Provide L2/L3 production support and manage user roles, security and master data.
• Collaborate with Manufacturing IT, QA and operations for requirements and tech transfers.
• Maintain validation documents and support audits and periodic reviews.

Skills

Syncade

CSV

GxP

Validation

Job description

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