Senior Engineer

2 days ago

Thousand Oaks, California, United States Belcan Full time
Job Title: Senior Engineer

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.
Requirements:
  • 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
Preferred 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.
About Belcan:

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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