Syncade MES Validation Engineer (CSV/Process)

Cognizant; Limerick; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Syncade

CSV

GxP

Validation

Jobbeschreibung

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.