Senior MES Validation Lead - Syncade & GxP Compliance

Cognizant Technology Solutions Corporation; Cork; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Cognizant Technology Solutions Corporation seeks an experienced Lead MES Validation Engineer to define and drive validation strategies for Syncade MES within a GxP manufacturing setting. You will mentor a validation team and ensure compliance with regulatory requirements and data integrity standards.

You will lead deliverable creation, oversee testing across systems (DeltaV, SAP, LIMS), and collaborate with QA, Manufacturing IT and vendors to achieve inspection-ready validation across sites.

Qualifications

• Lead validation strategy for Syncade MES and related systems in a GxP environment.
• Ensure electronic batch records and integrations are validated per GAMP 5 and 21 CFR Part 11 / EU Annex 11.
• Mentor validation team and drive inspection-ready compliance and data integrity.

Responsabilités

• Lead the validation strategy planning and execution for Syncade MES projects, upgrades and site rollouts using a risk-based GAMP 5 approach.
• Author and review validation deliverables including validation plans, URS, FS/DS, IQ/OQ/PQ protocols, risk assessments, traceability matrices and summary reports.
• Oversee testing of Syncade EBRs, master recipes, workflows and integrations with DeltaV, SAP, LIMS and historians.
• Ensure compliance with 21 CFR Part 11, EU Annex 11 and data integrity (ALCOA+) including audit trails and electronic signatures.
• Manage change controls, deviations, CAPAs and impact assessments to keep systems validated.

Connaissances

GxP leadership

GAMP 5

Regulatory compliance

Validation strategy

Mentoring

Risk-based testing

Data integrity (ALCOA+)

Audit readiness

Outils

DeltaV

SAP

LIMS

Description du poste

Cognizant Technology Solutions Corporation seeks an experienced Lead MES Validation Engineer to define and drive validation strategies for Syncade MES within a GxP manufacturing setting. You will mentor a validation team and ensure compliance with regulatory requirements and data integrity standards.

You will lead deliverable creation, oversee testing across systems (DeltaV, SAP, LIMS), and collaborate with QA, Manufacturing IT and vendors to achieve inspection-ready validation across sites.