Senior Engineer
2 days ago
We are seeking a highly skilled Senior Engineer to join our team at Belcan. As a Senior Engineer, you will be responsible for organizing Technology Transfer activities for Final Drug Product (FDP) manufacturing.
Key Responsibilities:- Support and create project schedules, dashboards, and lead team meetings to progress the project towards final objectives.
- Work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.
- Build effective Tech Transfer plans and schedules for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.
- Support Tech Transfer project scheduling activities for FDP.
- Support New Product Introduction to Client manufacturing site.
- Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
- Support engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
- Develop, track, and provide project dashboard updates.
- Provide good communication plans to cross-functional teams and Process Engineer management.
- Ability to apply project management and engineering science to production.
- Strong teamwork and excellent interpersonal and communication skills.
- Masters degree
- OR Bachelors degree and 2 years of experience
- OR Associates degree and 6 years of experience
- OR High school diploma/GED and 8 years of experience
- Experience in the Combination Product field, focusing on project management and/or manufacturing.
- Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.
- Knowledge of Combination Product design controls and regulatory requirements on a global scale.
- Familiarity with Client's commercialization framework.
- Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).
- PMP certification is desired.
Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide.
EOE/F/M/D/V
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