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Smart Plant & Manufacturing Strategy Manager(m/w/x)
Leading MES recipe authoring and GMP-compliant manufacturing system integrations for pharmaceutical clients. 5+ years in digital manufacturing consulting required. Client-facing engagements, validation support, and go-live activities.
Requirements
- Degree in Engineering, Pharmaceutical Sciences, Chemical Engineering, or IT
- 5+ years in management consulting, digital manufacturing, or industrial technology
- Strong track record in client-facing roles
- Practical experience in MES implementations
- MES: MBR/EBR authoring, validation support, go-live activities
- Solid understanding of manufacturing systems landscape
- MES in context of DCS/SCADA, ERP, LIMS, historian systems
- Knowledge of IT/OT convergence
- Advise clients on cross-system dependencies and integration
- Experience leading teams or workstreams
- Quality review of deliverables
- Structured and coaching-oriented leadership approach
- Knowledge of GxP regulatory frameworks
- GxP: FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSV
- Consulting acumen
- Ability to structure complex problems
- Develop client-ready communications
- Contribute to business development and proposals
- Strong communication and presentation skills in English
- Fluent German (mandatory)
- Entrepreneurial mindset
- Client presence
- Drive to build and shape practice area
Tasks
- Lead client engagements and manage MES Recipe Authors
- Ensure consistent quality and on-time delivery of projects
- Adhere to GMP and client-specific standards
- Review and approve MBRs, EBRs, and workflow configurations
- Advise on manufacturing systems landscape and integration
- Define coherent target architectures for clients
- Support MES roadmaps and platform selection
- Translate business and regulatory requirements into project plans
- Develop and improve authoring standards and review frameworks
- Create reusable assets and accelerators for engagements
- Act as a trusted advisor for senior client stakeholders
- Lead workshops, design sessions, and steering committee updates
- Contribute to proposals and client presentations
- Identify expansion opportunities within existing and new clients
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Fluent
Tools & Technologies
- MES
- Körber PAS|X
- Rockwell FactoryTalk PharmaSuite
- Siemens Opcenter
- MBR/EBR
- DCS/SCADA
- ERP
- SAP
- LIMS
- historian systems
- IT/OT convergence
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Computer System Validation (CSV)
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Smart Plant & Manufacturing Strategy Manager(m/w/x)
Leading MES recipe authoring and GMP-compliant manufacturing system integrations for pharmaceutical clients. 5+ years in digital manufacturing consulting required. Client-facing engagements, validation support, and go-live activities.
Requirements
- Degree in Engineering, Pharmaceutical Sciences, Chemical Engineering, or IT
- 5+ years in management consulting, digital manufacturing, or industrial technology
- Strong track record in client-facing roles
- Practical experience in MES implementations
- MES: MBR/EBR authoring, validation support, go-live activities
- Solid understanding of manufacturing systems landscape
- MES in context of DCS/SCADA, ERP, LIMS, historian systems
- Knowledge of IT/OT convergence
- Advise clients on cross-system dependencies and integration
- Experience leading teams or workstreams
- Quality review of deliverables
- Structured and coaching-oriented leadership approach
- Knowledge of GxP regulatory frameworks
- GxP: FDA 21 CFR Part 11, EU Annex 11, GAMP 5, CSV
- Consulting acumen
- Ability to structure complex problems
- Develop client-ready communications
- Contribute to business development and proposals
- Strong communication and presentation skills in English
- Fluent German (mandatory)
- Entrepreneurial mindset
- Client presence
- Drive to build and shape practice area
Tasks
- Lead client engagements and manage MES Recipe Authors
- Ensure consistent quality and on-time delivery of projects
- Adhere to GMP and client-specific standards
- Review and approve MBRs, EBRs, and workflow configurations
- Advise on manufacturing systems landscape and integration
- Define coherent target architectures for clients
- Support MES roadmaps and platform selection
- Translate business and regulatory requirements into project plans
- Develop and improve authoring standards and review frameworks
- Create reusable assets and accelerators for engagements
- Act as a trusted advisor for senior client stakeholders
- Lead workshops, design sessions, and steering committee updates
- Contribute to proposals and client presentations
- Identify expansion opportunities within existing and new clients
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Fluent
Tools & Technologies
- MES
- Körber PAS|X
- Rockwell FactoryTalk PharmaSuite
- Siemens Opcenter
- MBR/EBR
- DCS/SCADA
- ERP
- SAP
- LIMS
- historian systems
- IT/OT convergence
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Computer System Validation (CSV)
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Capgemini
Industry
Manufacturing
Description
Capgemini ist ein globaler Business- und Technologie-Transformationspartner für Organisationen, der bei der digitalen und nachhaltigen Transformation unterstützt.
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