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3key Consulting, Inc.

Engineer – Biotech, Drug Delivery Device & Packaging (JP14627)

3key Consulting, Inc., New Albany, Ohio, United States, 43054

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Job Title

Engineer – Biotech, Drug Delivery Device & Packaging (JP14627)

Location

New Albany, OH. 43054

Employment Type

Contract

Business Unit

Manufacturing Science & Technology

Duration

2 years with possible extensions and/or conversion to permanent

Posting Date

10/15/2025

Pay Rate

$40 - $44/hour W2

Notes

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, SmartSheet (project scheduling software), project management experience in a supporting role.

Desired: Engineering Background

Job Description

In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.

Responsibilities 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 company 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.

Why Position Open

Supplement additional workload on team

Top Must Have Skills 1- 2 years of experience post‑graduation

Tech Transfer

Engineering

Project Management

Basic Qualifications

Master’s degree OR Bachelor’s degree and 2 years of experience OR Associate’s degree and 6 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 Company’s commercialization framework.

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

Additional Skills Proactive risk assessment, management, and mitigation.

Ability to lead and succeed in an ambiguous environment.

Strong project management skills.

Red Flags This is not a Project Manager role, it is an engineer role with project management skills

This position does not include relocation package

Prefer candidates in Ohio - Columbus/New Albany

Contact

Email: resumes@3keyconsulting.com

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