Device Engineer – GMP Manufacturing Support & Mechanical Testing (JP15754)

3key Consulting, Inc.; New Albany (OH); On-site; USD 43,000 - 48,000; Part time

Benefits offered by this job

Onsite 5 days/week

Job summary

3key Consulting, Inc. is seeking a Device Engineer for GMP manufacturing support and mechanical testing in New Albany, OH. This contract role involves hands-on engineering in a regulated environment, ensuring quality systems are followed and issues are triaged, tested, and documented.

The ideal candidate has GMP experience, strong documentation skills, and familiarity with mechanical testing tools such as Instron, with CAD/SolidWorks being a plus. Onsite work is required, with potential overtime.

Qualifications

• GMP manufacturing experience and documentation practices.
• Experience with quality systems and ISO standards.
• Strong communication and technical writing.
• Proficiency with Instron testing and measurement methods.

Responsibilities

• Collaborate cross-functionally with SMEs to identify device issues and root causes.
• Expand documentation of site capability and control strategies.
• Ensure expedited communication to the wider team on risks to device manufacturing.
• Authors and reviews protocols, reports, and technical assessments.
• Analyze data using statistical methods to support decisions.
• Coordinate and execute laboratory testing for characterization and design transfer.
• Maintain design history files for assigned products.
• Develop characterization test methods through fixture prototyping and GR&R analysis.
• Provide subject matter expertise in system-level root cause analysis and change controls.
• Provide general lab support including inventory and sample shipments.
• Work with scientists and engineers to develop design/manufacturing specs.
• Represent device engineering within a large matrix organization.

Skills

GMP manufacturing

Instron systems

Technical writing

CAD SolidWorks

Cross-functional teamwork

Education

Engineering degree (Bachelor or higher)

Tools

SolidWorks

Job description

Device Engineer – GMP Manufacturing Support & Mechanical Testing (JP15754)

• New Albany, OH
• Biotech/Pharmaceutical

Job Title: Device Engineer – GMP Manufacturing Support & Mechanical Testing (JP15754)

Location: New Albany, OH 43054

Employment Type: Contract

Business Unit: Commercial Drug Product

Duration: 1+ year (with likely extensions and/or conversion to permanent)

Posting Date: 08/20/2026

Pay Rate: $31 - $35/hour W2

Notes: Only qualified candidates need apply. Fully Onsite (5 Days per Week) standard hours. Potential overtime.

3 Key Consulting is hiring a Device Engineer – GMP Manufacturing Support & Mechanical Testing

for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Our ideal candidate:

• Hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methods
• Proficiency in technical documentation and teamwork.
• Hands-on experience working within a GMP manufacturing environment is required, including familiarity with GMP documentation practices, manufacturing operations, and quality systems.
• Experience in regulated industries, preferably biopharma, biomedical, or medical devices, is strongly preferred, though aerospace or mechanical disciplines are acceptable provided the candidate also has relevant GMP manufacturing experience.
• Proficiency in Microsoft Office is required, and CAD/SolidWorks skills are a plus.
• Entry-level candidates with practical experience, such as internships within a GMP manufacturing or similarly regulated production environment, are preferred.

The Device Engineer will provide technical engineering support for material and component-related issues associated with commercial drug delivery devices and manufacturing operations. The primary focus of this role will be the triage, testing, investigation, escalation, and documentation of material-related issues identified during manufacturing or through other quality and technical support processes.

The engineer will work closely with Manufacturing, Quality, Engineering, and other cross-functional partners to assess reported issues, determine appropriate testing and investigation strategies, generate and review technical data, and support timely disposition or escalation of issues.

Scope includes mechanical delivery devices and associated components, including prefilled syringe systems. The qualified candidate will be part of a sustaining device engineering team supporting commercial manufacturing and product lifecycle activities. This position requires strong attention to detail, hands‑on technical capabilities, and the ability to accurately document work within a GMP‑regulated environment.

Why is the Position Open?

Supplement additional workload on team

Top Must Have Skills:

• Strong Communication
• Experience in a GMP Manufacturing Environment
• Strong Technical Writing
• Soft skills that need to be screened for: Looking for a self starter, someone who is ambitious

Day to Day Responsibilities:

• Collaborate Cross-Functionally with the Various SMEs at the FDP Manufacturing Sites to Identify Device Issues and Root Causes
• Expanding Documentation of Site Capability and Control Strategies
• Ensuring Expedited communication to wider team on risks to device manufacturing
• Authors and reviews technical documentation including protocols, reports, and technical assessments
• Analyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisions
• Coordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish efforts
• Maintains combination product design history files for assigned products
• Develops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysis
• Provides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessments
• Provide general laboratory support including inventory management, sample shipments, and cleanup.
• Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specifications
• Individual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organization

Basic Qualifications:

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• At a minimum familiar with the following standards and regulations:
  • Quality System Regulation – 21CFR820
  • Risk Management – ISO 14971
  • EU Medical Device requirements – Council Directive 93/42/EEC
• Demonstrates experience working in a GMP manufacturing environment and adheres to strict GMP documentation and compliance practices
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments, plans and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures and criteria and devises new approaches to problems encountered.

Preferred Qualifications:

• Bachelor’s Degree or higher in relevant engineering or scientific field (Mechanical, Biomedical, Bioengineering)
• Minimum 2 years of scientific or engineering experience working in a GMP regulated manufacturing environment
• Demonstrated understanding of GMP manufacturing operations, documentation practices, deviations/change controls, and working within an established quality system
• Statistical Analysis software (Minitab or JMP)
• Strong technical writing skills
• CAD fixturing software (SolidWorks)
• Tolerance Stack-Ups (2D, 3D, RSS)
• Instron force tester using BlueHill Universal
• CT-Scanning
• Deviations and CAPAs
• Experience with design controls; including (but not limited to) verification and design transfer
• Understanding of risk assessments including hazard and probability analysis
• Background in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)
• Ability to work independently and dynamically across functional teams
• Excellent written and verbal communication skills
• Ability to support complex workstreams under demanding timelines

Employee Value Proposition:

Unique industry opportunity, industry experience

Red Flags:

• No Cross-Functional Experience
• No Practical Work Experience

Interview process:

• Initial 1:1 Phone Interview with Hiring Manager
• Group Interview with CORE SMEs