Work Flexibility: Onsite
What you need
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
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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.
Preferred:
- Experience of process mapping, statistical methods and process/product validations
- Experience leading construction and utilities installation.