What you will do

• Assumes full responsibility for the successful initiation, planning, execution, monitoring, control, and closure of the project, ensuring delivery within scope, schedule, cost, and quality.
• Leads capital acquisition activities including vendor selection, purchase, installation, validation, and handover of machines, equipment, tooling, and fixtures.
• Defines and maintains project scope and schedule, taking ownership of progress tracking and reporting.
• Collaborates with Product Development, Advanced Technology, Global Marketing, and Manufacturing Operations to ensure seamless project implementation and optimal process integration.
• Participates in the selection, training, and performance evaluation of project resources, including contract subject matter experts as needed.
• Identifies, monitors, and manages project risks, ensuring compliance with engineering principles and internal policies.
• Analyzes equipment performance, conducts tests, reviews results, and may lead or participate in process review meetings.
• Ensures GMP and safety compliance, selects components based on regulatory and reliability requirements, approves validation documentation, and supports quality testing protocols.

What you need
 

Required:

• Bachelor’s degree in Engineering discipline.
• 5+ years of experience in technical or project management role.
• Experience with New Product Introduction in an FDA regulated industry.
• Bilingual: English & Spanish.
• Demonstrated experience with Microsoft products - Excel, Access, PowerPoint, MS Project required.
• Available to work under a 18-month contract.

Preferred:

• Experience of process mapping, statistical methods and process/product validations
• Experience leading construction and utilities installation.