Process Engineer

Job Title: Process Engineer

Duration: 24 plus months’ contract

Location: New Albany, OH 43054

Type of Position: Only on W2 basis

Onsite Ohio - 5 days a week.

Ideal Candidate:

B.S. 3+ YOE, Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products. Engineering Background.

Skills: Strong English written and verbal communication skills, MS Office, Smartsheet (project scheduling software), project management experience in a supporting role.

Key Responsibilities:

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.

Supporting New Product Introduction to Client 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.

Ability to apply project management and engineering science to production.

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 Client’s commercialization framework.

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

Regards

Satya S

Sr. Operations Manager

Phone #: