21.10.2026 aktualisiert
100 % verfügbar
Senior MES / CSV Consultant | PharmaSuite & Syncade | EBR/MBR | GMP | Pharmaceutical Manufacturing
Cork, Irland
Nur Remote
Master of Computer Applications (MCA) - Devi Ahilya UniversityÜber mich
Senior MES/CSV Consultant with 14+ years’ experience in PharmaSuite & Syncade across GMP sites in Ireland, Europe, and the USA. Expert in MES recipe authoring, EBR/MBR, change control, validation (IQ/OQ/UAT), and digital validation using Kneat & HP ALM.
Skills
MES Platforms & Delivery
Expertise in Rockwell FactoryTalk PharmaSuite and Emerson Syncade, covering end-to-end MES delivery including architecture, functional requirements, process mapping, recipe authoring, workflow design and review, EBR/MBR, implementation, upgrades, enhancements, and migration across GMP-regulated pharmaceutical environments.
Computer System Validation (CSV) & Compliance
Comprehensive knowledge of CSV, URS, FDS, IQ, OQ, UAT, GAMP 5, 21 CFR Part 11, ALCOA+, and GMP standards, with hands-on experience authoring and executing validation documentation using Kneat and HP ALM / Quality Center.
MES Integration & Automation
Proficiency in MES-Automation integration using OPC/Kepware, equipment model design and configuration, and cross-functional collaboration with Manufacturing, QA, Validation, Automation, and IT teams to ensure compliant and production-ready MES solutions.
ISA-88 / ISA-95 Standards
Application of ISA-88 and ISA-95 standards in the design and delivery of MES solutions, including EBRs, MBRs, recipes, workflows, and reusable MES building blocks aligned with global pharmaceutical manufacturing standards.
Change Control & Impact Assessment
Execution of impact assessments, delta analysis, and change control processes for MES enhancements and system upgrades within GMP-regulated environments.
SQL Server & Tools
Working knowledge of SQL Server, ServiceNow, HP ALM / Quality Center, and Kneat for MES support, validation, and project management activities.
Stakeholder & Project Management
Stakeholder management, cross-functional leadership, change control, risk management, and end-to-end MES implementation and validation across global pharmaceutical sites in Ireland, USA, and Europe.
Software Engineering Foundation
Strong foundation in software development, databases, and industrial systems built through early career experience at Satyam Computer Services / Tech Mahindra, Robert Bosch, and Siemens, supporting manufacturing, automation, and enterprise applications.
Six Sigma & Agile
Certified Six Sigma Yellow Belt and SAFe Agilist, supporting structured problem-solving and agile delivery methodologies in complex project environments.
Expertise in Rockwell FactoryTalk PharmaSuite and Emerson Syncade, covering end-to-end MES delivery including architecture, functional requirements, process mapping, recipe authoring, workflow design and review, EBR/MBR, implementation, upgrades, enhancements, and migration across GMP-regulated pharmaceutical environments.
Computer System Validation (CSV) & Compliance
Comprehensive knowledge of CSV, URS, FDS, IQ, OQ, UAT, GAMP 5, 21 CFR Part 11, ALCOA+, and GMP standards, with hands-on experience authoring and executing validation documentation using Kneat and HP ALM / Quality Center.
MES Integration & Automation
Proficiency in MES-Automation integration using OPC/Kepware, equipment model design and configuration, and cross-functional collaboration with Manufacturing, QA, Validation, Automation, and IT teams to ensure compliant and production-ready MES solutions.
ISA-88 / ISA-95 Standards
Application of ISA-88 and ISA-95 standards in the design and delivery of MES solutions, including EBRs, MBRs, recipes, workflows, and reusable MES building blocks aligned with global pharmaceutical manufacturing standards.
Change Control & Impact Assessment
Execution of impact assessments, delta analysis, and change control processes for MES enhancements and system upgrades within GMP-regulated environments.
SQL Server & Tools
Working knowledge of SQL Server, ServiceNow, HP ALM / Quality Center, and Kneat for MES support, validation, and project management activities.
Stakeholder & Project Management
Stakeholder management, cross-functional leadership, change control, risk management, and end-to-end MES implementation and validation across global pharmaceutical sites in Ireland, USA, and Europe.
Software Engineering Foundation
Strong foundation in software development, databases, and industrial systems built through early career experience at Satyam Computer Services / Tech Mahindra, Robert Bosch, and Siemens, supporting manufacturing, automation, and enterprise applications.
Six Sigma & Agile
Certified Six Sigma Yellow Belt and SAFe Agilist, supporting structured problem-solving and agile delivery methodologies in complex project environments.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2026
Sprachen
EnglishMuttersprache
Projekthistorie
Supporting Rockwell FactoryTalk PharmaSuite MES delivery within a GMP-regulated biopharmaceutical environment, covering FRS, process mapping, Master Recipe development/review, and Syncade-to-PharmaSuite migration across Chrome/MEDIA, USP, and downstream processing/cleaning. Supporting IQ/OQ and validation activities for recipe configuration, workflow behaviour, and migrated functionality. Collaborating with Manufacturing, QA, Validation, Automation, and IT to support GMP-compliant MES delivery and production readiness.
Supported global Rockwell FactoryTalk PharmaSuite standardisation and rollout, including EBRs, MES workflows, Unit Procedures, and validation using HP ALM. Collaborated with Rockwell Automation on PharmaSuite enhancements and provided Level 4 production support, including issue resolution and root-cause analysis. Location: Sanford, USA. Project-based assignments.
Delivered validated Emerson Syncade MES enhancements and change controls within a GMP-regulated pharmaceutical manufacturing environment. Configured and enhanced MES recipes and Electronic Batch Records (EBRs) supporting manufacturing operations. Performed impact assessment, delta analysis, and change control for MES enhancements and system upgrades. Authored and maintained URS/FDS and executed IQ, OQ, and UAT using Kneat and HP ALM in accordance with GAMP 5. Supported MES production issues and controlled releases, collaborating with Manufacturing, QA, Automation, and IT teams.