Process Engineer

Job Title: Engineer

Location: New Albany Ohio (Ohio)

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.

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.

About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

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