Project Engineer

For Leading and Executing Labeling Update Projects in the Project Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least five (5) years of experience in validation, labeling, quality, manufacturing, or other regulated industry environments. 
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  •  Leading labeling update projects and managing change controls through implementation.
  • Executing validation activities, including protocol development and qualification documentation.
  • Working knowledge of FDA QSR, ISO 13485, GMP requirements, and regulated manufacturing practices.
  • Experience using Microsoft Project, PLM/ERP systems, and collaborating with cross-functional teams to deliver projects.

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

• Lead and execute labeling update projects, ensuring timely implementation and compliance with applicable regulatory and quality requirements.
• Manage labeling-related change control activities from initiation through closure, including implementation planning, documentation updates, verification, stakeholder communication, and effectiveness checks.
• Coordinate cross-functional activities with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Product Development, Engineering, and IT teams.
• Author, review, and execute validation documentation, including validation plans, protocols, test scripts, reports, risk assessments, and impact assessments, as required.
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for labeling equipment, printing systems, software, and related processes, when required.
• Support qualification and implementation of new label materials, printers, barcode systems, vision systems, and labeling software, when required.
• Investigate and resolve issues encountered during labeling updates, validation activities, or implementation efforts.
• Assess existing labeling processes and documentation as required, identify risks, gaps, and compliance concerns, and recommend corrective or preventive actions.
• Develop, maintain, and monitor project schedules using Microsoft Project and provide regular status updates to stakeholders, as required.
• Drive continuous improvement initiatives focused on labeling processes, project execution, compliance, and operational efficiency.
• Ensure all project documentation complies with company procedures, GMP requirements, quality system standards, and data integrity expectations.
• Utilize Microsoft Office applications to support project planning, reporting, documentation, data analysis, and presentations.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?