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Senior Technology Transfer Engineer

1 month ago

Thousand Oaks, California, United States Belcan Full time
Job Summary

We are seeking a highly skilled Senior Technology Transfer Engineer to join our team at Belcan. In this role, you will be responsible for organizing Technology Transfer activities for Final Drug Product (FDP) manufacturing. This includes supporting and creating project schedules, dashboards, and leading team meetings to progress the project towards final objectives.

As a Senior Technology Transfer Engineer, you will 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. Your role will focus on building effective Tech Transfer plans and schedules for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.

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 New Product Introduction to Client manufacturing site

Own 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

Master's degree

OR Bachelor's degree and 2 years of experience

OR Associate's 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

Additional Skills

Proactive risk assessment, management, and mitigation

Ability to lead and succeed in an ambiguous environment

Strong project management skills

Belcan

We are 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. For more information, please visit our website at

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