Project Manager
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- Bayamón, PR
- Permanente
- Tiempo completo
- Lead implementation, upgrade, and optimization projects for MES / eBR systems (e.g., POMSnet, Advance eBR, Enhance PCI)
- Manage cross-functional teams including IT, Quality, Manufacturing, and Validation
- Oversee the full project lifecycle: planning, execution, monitoring, and closure
- Ensure compliance with GMP and CSV/CSA requirements
- Manage project documentation, validation protocols, and deliverables
- Identify risks and develop mitigation strategies
- Act as the primary liaison between technical teams and business stakeholders
- Support broader digital transformation initiatives within manufacturing
- Bachelor's degree in Engineering (Industrial, Chemical, Mechanical, Computer, or related field)
- 5+ years of experience in pharmaceutical or medical device manufacturing environments
- Proven experience leading projects involving:
- Manufacturing Execution Systems (MES)
- Electronic Batch Records (eBR)
- Hands-on experience with at least one of the following systems:
- POMSnet
- Advance eBR
- Enhance PCI
- Strong understanding of GMP environments
- Experience with Computer System Validation (CSV) or CSA
- Demonstrated ability to manage cross-functional teams and stakeholders
- PMP certification or equivalent
- Experience integrating systems (ERP, LIMS, etc.)
- Knowledge of data integrity and regulatory compliance
- Experience in digital transformation or Industry 4.0 initiatives
- Bilingual (English/Spanish)
- Competitive salary based on experience
- Opportunity to lead high-impact projects
- Exposure to digital transformation initiatives in pharma manufacturing
- Collaborative and dynamic work environment