Process Development Engineer

ACL Digital; New Albany (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading biotech company is seeking a Process Engineer/Tech Transfer for a 2-year contract in New Albany, Ohio. The ideal candidate should possess a Bachelor's degree with 3+ years of experience in the biotech and pharma sectors, particularly in GMP environments. Responsibilities include organizing Technology Transfer activities, creating project schedules, and working across global teams to support new product introductions at the Amgen manufacturing site. Strong English communication and project management skills, alongside experience with combination products, are essential.

Qualifications

• Bachelor’s degree in relevant field and 2 years of experience.
• Proven experience in Tech Transfer of Combination Products.
• Knowledge of project management in a GMP setting.

Responsibilities

• Organize Technology Transfer activities for Final Drug Product manufacturing.
• Support and create project schedules for manufacturing capabilities.
• Lead meetings and track project progress towards objectives.

Skills

Strong English written and verbal communication skills

MS Office

Smartsheet

Project management experience in a supporting role

Experience in Tech Transfer

Proactive risk assessment

Education

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

Tools

MS Project

Smartsheet

Job description

Job Title: Process Engineer/Tech Transfer

Location: New Albany OH

Duration: 2 years contract

Description

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

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.

Top 3 Must Have Skill Sets

• Process Engineer
• must have combination product

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 Amgen 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

• 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

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 Amgen’s commercialization framework.

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

Additional Skills

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