Sr Manufacturing Application Project Manager(Remote)
Role: Senior Manufacturing Application Project Manager Location: Juncos, PUERTO RICO – Remote 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#, , .NET CoreSQL ServerWPF 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) environments5+ 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 11GAMP (Good Automated Manufacturing Practice)ISO 13485FDA 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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