Senior Process Engineer
Listed on 2025-12-21
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Engineering
Manufacturing Engineer, Quality Engineering
Senior Executive – US TAG at ACL (Pharmaceuticals, Life Sciences and Medical Devices)
Job Title: Senior Process Engineer
Location: New Albany, OH
Duration: 2 years
Description: Onsite Ohio - 5 days a week. Schedule 8am-5pm, flexible, OT 10% peak.
Ideal Candidate: Experience in biotech/pharma, GMP, manufacturing, tech transfer, combination products.
Skills: Strong English communication, MS Office, Smart Sheet, project management background.
Desired: Engineering background.
Top 3 Must Have Skill Sets: 4-5 YOE. Please do not submit resumes that have mostly PM experience. Project Management.
Key Responsibilities:Organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.
Support and create project schedules, lead site assessment and manufacturing capabilities, update dashboards, lead team meetings to progress project towards final objectives. Work across global cross-functional team: manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, regulatory.
Focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in GMP setting.
Support New Product Introduction to Amgen manufacturing site.
Own documentation:
Project Plan, engineering support for Process Transfer Documents (PTD), protocols, 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.
Strong teamwork and excellent interpersonal and communication skills.
Basic Qualifications:- Bachelor’s degree and 2 years of experience
- Associate’s degree and 6 years of experience
- High school diploma/GED and 8 years of experience
Experience in Tech Transfer of Combination Product, focusing on project management and/or manufacturing.
Understanding of interdependencies of complex projects, especially new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and regulatory requirements globally.
Familiarity with Amgen’s commercialization framework.
Program and Project Management skills (MS Project, Smart Sheets desired).
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