Senior Engineer- Tech Transfer

Infotree Global Solutions provided pay range

This range is provided by Infotree Global Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$50.00/hr - $55.00/hr

Onsite Ohio - 5 days a week.

Schedule is typically 8am - 5pm (some flexibility with schedule, may be expected to work OT 10% of the time during peak season).

Ideal Candidate:

Experience:

Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.

Skills:

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

Desired:
Engineering Background.

• Organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.
• Support and create project schedules; lead site assessment and manufacturing capabilities; update project dashboards; 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.
• Lead effective Tech Transfer projects 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, support 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.
• Apply project management and engineering science to production.
• Demonstrate strong teamwork and excellent interpersonal and communication skills.

• 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

• 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 commercialization framework.
• Program and Project Management skills (experience with MS Project, Smart Sheets, and other project scheduling software desired).

• Proactive risk assessment, management, and mitigation.
• Ability to lead and succeed in an ambiguous environment.

• 4-5 YOE
• Project Management

Mid‑Senior level

Contract

Biotechnology Research and Pharmaceutical Manufacturing

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