Lead MES Syncade Validation Engineer

Cognizant; Cork; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GxP leadership

GAMP 5

Regulatory compliance

Validation strategy

Mentoring

Risk-based testing

Data integrity (ALCOA+)

Audit readiness

Strumenti

DeltaV

SAP

LIMS

Descrizione del lavoro

Job Summary

Lead MES Validation - The Lead MES Syncade Validation Engineer leads the validation strategy and execution for Syncade MES and related systems in a GxP-regulated life science manufacturing environment. The role ensures electronic batch records recipes and integrations are validated per GAMP 5 21 CFR Part 11 and EU Annex 11 while mentoring the validation team and maintaining inspection-ready compliance and data integrity.

Responsibilities

• 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 risk assessments IQ/OQ/PQ protocols traceability matrices and summary reports
• Oversee testing of Syncade EBRs master recipes workflows and integrations with DeltaV ERP (e.g. SAP) LIMS and historians
• Ensure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements including audit trails and electronic signatures
• Manage change controls deviations CAPAs and impact assessments to keep systems in a validated state throughout the lifecycle
• Provide technical leadership mentoring and work direction to validation engineers testers and contractors
• Collaborate with QA Manufacturing IT Automation and vendors to align requirements resolve test failures and approve deliverables
• Define and maintain validation SOPs templates and standards and drive adoption of global validation practices across sites
• Support periodic reviews internal audits and regulatory inspections as the subject matter expert for Syncade validation
• Identify opportunities to streamline validation through automation reusable test scripts and computer software assurance (CSA) principles