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Cross-Functional Coordination
This role requires active cross-functional coordination with business teams to ensure priorities, use case definitions, and acceptance criteria are aligned with the technical delivery roadmap.
Key Responsibilities
Translate business requirements into detailed technical specifications and solution designs for OEE, Connected Worker, and Golden Batch use cases
Lead and coordinate the integration workstream end-to-end; drive delivery ownership and escalation
Act as the primary point of contact for cross-functional stakeholders; facilitate alignment sessions across business, technical, and integration teams
Own technical design documents, integration specifications, and data flow diagrams
Govern risks/issues, project plan; represent GMSx in steering ceremonies and SAFe ceremonies
Drive cross-functional coordination with business teams to align priorities with technical delivery
Define technical implementation steps and ensure traceability between business needs and technical deliverables
Support UAT planning and coordinate with business stakeholders for validation
Provide guidance on best practices for MDF platform utilization within the GMSx program
Required Qualifications & Experience
8+ years of experience in techno-functional roles within manufacturing, pharmaceutical, or life sciences domains
Proven track record of leading OT/IT integration projects and converting complex business requirements into technical solutions
Deep understanding of OEE calculations, batch processing workflows, and connected worker concepts in a manufacturing context
Strong project management skills - ability to plan, prioritize, and drive delivery independently across multiple workstreams
Experience guiding Computer System Validation (CSV) for Edge Gateway or similar integration platforms, preferably in GxP environments
Familiarity with GxP-regulated environments and relevant regulatory frameworks (FDA 21 CFR Part 11, EU Annex 11)
Solid understanding of data management principles (data flows, naming conventions, data governance)
Excellent stakeholder management and communication skills - ability to align global and local teams with different priorities
Experience with MES (e.g., PAS-X), MDF, or similar manufacturing data/execution platforms
Preferred / Nice-to-Have
Experience with SAFe Agile methodology in enterprise settings
Familiarity with ISA-95 / ISA-88 standards for manufacturing integration
Prior experience with large pharma/life sciences organizations
Knowledge of UNS (Unified Namespace) strategy and enterprise data governance frameworks
Kaleidoscope, an Infosys Company, is an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.
Numbers & Facts
Location
Parsippany-Troy Hills, NJ
Skills
Acceptance Testingunmatched
Agile Programming Methodologiesunmatched
Best Practicesunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Computer Systemsunmatched
Consultingunmatched
Cross-Functionalunmatched
Data Managementunmatched
Design Documentunmatched
Drug Manufacturingunmatched
Establish Prioritiesunmatched
FDA Requirementsunmatched
GxPunmatched
ISA Standardsunmatched
Manufacturingunmatched
People Managementunmatched
Project Planningunmatched
Project/Program Managementunmatched
Requirements Managementunmatched
System Validationunmatched
Technical Deliveryunmatched
Technical Writingunmatched
Technical/Engineering Designunmatched
Traceabilityunmatched
Use Casesunmatched
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