Engineer

Engineer

Top 3 Must Have Skill Sets:

1- 2 years of experience post graduation

Tech Transfer

Engineer

Project Management Red Flags:

This is not a Project Manager role, it is an engineer role with project management skills

This position does not include relocation package

Prefer candidates in Ohio - Columbus/New Albany

Summary:

In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.

Responsibilities include supporting and creating project schedules, lead site assessment and manufacturing capabilities, update project dashboards, and leading team meetings to progress the project towards final objectives. 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 leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.

Responsibilities:

Supporting New Product Introduction to our manufacturing site.

Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.

Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.

Developing, tracking, and providing project dashboard updates.

Providing 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.

Basic Qualifications:

Masterâ s degree OR

Bachelorâ s degree and 2 years of experience OR

Associateâ s degree and 6 years of experience OR

High school diploma/GED and 8 years of experience

Preferred Experience:

Experience in the Tech Transfer of 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 our commercialization framework.

Program and Project Management skills (experience with MS Project, SmartSheets, and other project scheduling software is desired).

Additional Skills:

Proactive risk assessment, management, and mitigation.

Ability to lead and succeed in an ambiguous environment.

Strong project management skills.

Pay range is $33 - $38 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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