Lead MES Syncade Validation Engineer

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