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.
Minimum 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 12-month contract.
Preferred:
Experience of process mapping, statistical methods and process/product validations
Experience leading construction and utilities installation.