{"id":3412789,"url":"https://alion.io/job/cognizant-lead-mes-syncade-validation-engineer","title":"Lead MES Syncade Validation Engineer","company":{"id":85,"name":"Cognizant","domain":"cognizant.com","url":"https://alion.io/company/cognizant","size_band":"5000+","is_staffing_agency":false,"employer_type":"services","is_intermediary":false,"listed_via":null,"ats_vendor":"Cognizant Careers","truth_index":{"grade":"A","score":86,"open_postings":160,"ghost_share":0,"stale_share":0.538,"repost_share":0.019,"time_to_fill_p50_days":22,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Enterprise Apps","role_family":"Enterprise Apps","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cork, Ireland"],"countries":["IE"],"hiring_countries":["IE"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"LIMS","optional":false}],"status":"live","first_seen_at":"2026-10-28T09:30:00Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-11-01T12:51:32Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Job Summary\nLead 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.\nResponsibilities\nLead the validation strategy planning and execution for Syncade MES projects upgrades and site rollouts using a risk-based GAMP 5 approach\nAuthor and review validation deliverables including validation plans URS FS/DS risk assessments IQ/OQ/PQ protocols traceability matrices and summary reports\nOversee testing of Syncade EBRs master recipes workflows and integrations with DeltaV ERP (e.g. SAP) LIMS and historians\nEnsure compliance with 21 CFR Part 11 EU Annex 11 and data integrity (ALCOA+) requirements including audit trails and electronic signatures\nManage change controls deviations CAPAs and impact assessments to keep systems in a validated state throughout the lifecycle\nProvide technical leadership mentoring and work direction to validation engineers testers and contractors\nCollaborate with QA Manufacturing IT Automation and vendors to align requirements resolve test failures and approve deliverables\nDefine and maintain validation SOPs templates and standards and drive adoption of global validation practices across sites\nSupport periodic reviews internal audits and regulatory inspections as the subject matter expert for Syncade validation\nIdentify opportunities to streamline validation through automation reusable test scripts and computer software assurance (CSA) principles","description_format":"text","description_chars":1751,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"Ireland","iso":"IE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["IT Consulting & Digital Transformation","IT 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