Digital Quality, IT Project Quality Manager - MES
Core
Qualification and validation compliance of computerized Manufacturing Execution Systems (MES) used for cGMP activities to ensure digital infrastructure integrity for life-changing therapies.
Role type
Computer Systems Validation (CSV) Specialist for Manufacturing Execution Systems
Builds
Validated MES systems and related recipe lifecycle management for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Computer Systems Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer Systems Validation (CSV), Manufacturing Execution Systems (MES), cGMP, GAMP 5, FDA 21 CFR Part 11, EudraLex Annex 11, validation strategy creation, test script execution, technical documentation review, data integrity principles, audit support
Preferred skills
PharmaSuite, Syncade, MODA-ES, electronic validation tools (Kneat), Document Management Systems
Technologies
PharmaSuite, Syncade, MODA-ES, Kneat
Responsibilities
Create and maintain validation execution plans aligned with project timelines and budgets; Lead planning and execution of validation deliverables for MES implementations; Act as QA voice in cross-functional teams driving CSV standards; Ensure timely and compliant setup and execution of tests in Test Management System; Provide CSV guidance to project teams and assess impact of new regulatory guidance; Review and approve technical documentation including protocols and validation reports; Train project team members on IT requirements and advise on processes; Uphold data integrity principles and escalate risks; Support audits, inspections, and process qualification activities
Seniority
Mid-level specialist, hands-on execution
