NTT

1 month ago

Senior Manufacturing Application Project Manager

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Last checked: 17 hours agoStatus: Live

Job Summary

Lead complex MES and shop-floor integration projects in the life sciences/medical devices domain, ensuring delivery within scope, schedule, and budget. Manage project planning, budgets, and resources while coordinating cross-functional teams across IT, manufacturing, and quality. Oversee software validation/CSV, regulatory compliance (FDA 21 CFR Part 11, GAMP, ISO 13485), and stakeholder reporting. Integrate .NET-based systems with PLC/SCADA and enterprise systems, supporting eDHR adoption.

Location: Puerto Rico

Workplace: Onsite

Employment Type: Full time

Job Function: Program & Project Management (PMO)

Seniority: Manager level

Key Responsibilities

•Define project scope, objectives, deliverables, and detailed plans with timelines, milestones, and resource allocation.
•Drive MES-related initiatives using Agile or hybrid SDLC methodologies to deliver within scope, schedule, and budget.
•Lead and mentor teams of software engineers, automation experts, and QA professionals; delegate work and ensure accountability.
•Ensure compliance with FDA 21 CFR Part 11, GAMP, and ISO 13485, including cybersecurity, data integrity, and audit trail requirements.
•Oversee Computer System Validation (CSV), document configurations, manage validation deliverables, and support manufacturing/shop floor integration with .NET-based architecture and enterprise systems.

Key Requirements

•7+ years of hands-on experience with C#, ASP.NET, .NET Core, SQL Server, and WPF or Blazor for dashboards/HMI development.
•5+ years managing MES implementations in life sciences or medical devices (Class II/III) environments.
•5+ years of hands-on involvement in shop floor automation and integration.
•PMP or Certified Scrum Master (CSM) certification, plus strong understanding of Quality Management Systems (QMS).
•Mandatory experience in Computer System Validation (CSV) and eDHR implementation in highly regulated environments with strict documentation practices.

Experience:7+ yearsLife sciencesMedical devicesMESShop floor automationRegulated manufacturing

Skills:LeadershipStakeholder managementAnalytical/problem-solvingRisk managementCross-functional collaboration

Certifications:PMPCertified Scrum Master (CSM)

Languages:EnglishSpanish

Tech Stack:C#ASP.NET.NET Core.NETSQL ServerWPFBlazor.NET-basedAgileSDLCPLCSCADAERPMESCSVEDHRElectronic batch recordsElectronic Device History RecordsPLCs

Company Brief

NTT

Dimension Data, operating under NTT Ltd, provides managed IT services, cloud and data center solutions, networking, cybersecurity, and digital transformation services to enterprise customers worldwide.

Industry: Professional Services

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Valuation: Public Company (Market Cap in USD)

Headquarters: London, United Kingdom

Founded: 1983

Website LinkedIn

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NTT