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

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