Device Engineer – GMP Manufacturing Support & Mechanical Testing; JP

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.

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

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/Solid Works 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.

Supplement additional workload on team

• 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

• 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…