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