Senior Manufacturing Application Project Manager

Req ID:  373645  

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Senior Manufacturing Application Project Manager to join our team in Juncos, Puerto Rico (PR-PR), Puerto Rico (PR).

Job Title: Senior Manufacturing Application Project Manager (Medical Devices / Life Sciences)

Location: Juncos, Puerto Rico
Language Requirement: Bilingual (English & Spanish)

Position Overview

We are seeking an experienced Project Manager with a strong background in Manufacturing Execution Systems (MES) within the Life Sciences / Medical Devices domain. The ideal candidate will lead complex, cross-functional projects involving software validation, shop floor integration, and regulatory compliance, ensuring successful delivery within scope, schedule, and budget.

Key Responsibilities

Project Planning & Execution

• Define project scope, objectives, and deliverables in collaboration with senior leadership and stakeholders
• Develop and manage detailed project plans, including timelines, milestones, and resource allocation
• Drive execution of MES-related initiatives using Agile or hybrid SDLC methodologies

Budget & Resource Management

• Forecast project requirements and manage budgets effectively
• Track expenses, analyze variances, and implement corrective actions
• Optimize resource utilization across cross-functional teams

Team Leadership

• Lead and mentor diverse teams comprising software engineers, automation experts, and QA professionals
• Delegate tasks effectively, ensuring accountability and high performance
• Foster collaboration across IT, manufacturing, and quality functions

Risk & Compliance Management

• Identify and mitigate potential risks, issues, and bottlenecks proactively
• Ensure adherence to FDA 21 CFR Part 11 , GAMP , and ISO 13485 standards
• Enforce cybersecurity, data integrity, and audit trail requirements

Stakeholder Communication

• Act as the primary point of contact for project stakeholders
• Provide regular status updates, performance metrics, and executive reports
• Facilitate alignment between business, IT, and manufacturing teams

Quality Assurance & Validation

• Oversee Computer System Validation (CSV) activities, ensuring all configurations are documented and validated
• Ensure all deliverables meet quality standards and regulatory compliance
• Conduct post-project reviews and identify improvement opportunities

Manufacturing & Shop Floor Integration

• Manage .NET-based architecture integrating shop floor systems (PLCs, SCADA) with enterprise systems (ERP)
• Enable tracking of production metrics, genealogy, and electronic batch records
• Support transition to Electronic Device History Records (eDHR) systems

Required Qualifications

Technical Expertise

• 7+ years of strong hands-on experience with:
  • C#, ASP.NET, .NET Core
  • SQL Server
  • WPF or Blazor for dashboards / HMI development

Domain Experience

• 5+ years of proven experience 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

Certifications

• PMP (Project Management Professional) or Certified Scrum Master (CSM)
• Strong understanding of Quality Management Systems (QMS)

Regulatory Knowledge

• Expertise in:
  • FDA 21 CFR Part 11
  • GAMP (Good Automated Manufacturing Practice)
  • ISO 13485
  • FDA Design Controls

Validation & Compliance

• Mandatory experience in Computer System Validation (CSV)
• Experience with eDHR (Electronic Device History Records) implementation
• Ability to work in highly regulated environments with strict documentation practices

Preferred Skills

• Experience with Agile / hybrid delivery models
• Strong stakeholder management and communication skills
• Ability to operate in fast-paced, regulated manufacturing environments
• Familiarity with cybersecurity practices in medical manufacturing

Additional Requirements

• Bilingual communication skills (English & Spanish)
• Ability to work onsite or coordinate with plant operations in Juncos, PR
• Strong analytical and problem-solving capabilities

#LI-NorthAmerica

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form,

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