Device Engineer - GMP Manufacturing Support & Mechanical Testing

Device Engineer – GMP Manufacturing Support & Mechanical TestingLocation: New Albany, OH 43054 Employment Type: Contract Business Unit: Commercial Drug Product Duration: 1+ year (with likely extensions and/or conversion to permanent)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.Our ideal candidate:Hands-on experience in engineering environments, particularly with tools like Instron systems and optical measurement methodsProficiency 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 teamStrong CommunicationExperience in a GMP Manufacturing EnvironmentStrong Technical WritingLooking for a self starter, someone who is ambitiousDay to Day Responsibilities:Collaborate Cross-Functionally with the Various SMEs at the FDP Manufacturing Sites to Identify Device Issues and Root CausesExpanding Documentation of Site Capability and Control StrategiesEnsuring Expedited communication to wider team on risks to device manufacturingAuthors and reviews technical documentation including protocols, reports, and technical assessmentsAnalyze and trend generated data by applying relevant statistical techniques to enable senior staff to make informed decisionsCoordinates and executes laboratory testing to support characterization, verification, design transfer, and fill-finish effortsMaintains combination product design history files for assigned productsDevelops characterization test methods through fixture prototyping, reference sample creation, and GR&R analysisProvides functional subject matter expertise to actively participate in cross-functional activities including system level root cause analysis, design changes, and change control assessmentsProvide general laboratory support including inventory management, sample shipments, and cleanup.Works with Scientists and Engineers, to assess and develop appropriate design and manufacturing specificationsIndividual contributor with Leadership attributes to effectively represent device engineer within a large network/matrix organizationBasic 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 experienceAt a minimum familiar with the following standards and regulations:Quality System Regulation – 21CFR820Risk Management – ISO 14971EU Medical Device requirements – Council Directive 93/42/EECDemonstrates experience working in a GMP manufacturing environment and adheres to strict GMP documentation and compliance practicesFully 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 environmentDemonstrated understanding of GMP manufacturing operations, documentation practices, deviations/change controls, and working within an established quality systemStatistical Analysis software (Minitab or JMP)Strong technical writing skillsCAD fixturing software (SolidWorks)Tolerance Stack-Ups (2D, 3D, RSS)Instron force tester using BlueHill UniversalCT-ScanningDeviations and CAPAsExperience with design controls; including (but not limited to) verification and design transferUnderstanding of risk assessments including hazard and probability analysisBackground in medical device development, commercialization and knowledge of manufacturing processes (fill-finish)Ability to work independently and dynamically across functional teamsExcellent written and verbal communication skillsAbility to support complex workstreams under demanding timelinesEmployee Value Proposition: Unique industry opportunity, industry experienceRed Flags:No Cross-Functional ExperienceNo Practical Work ExperienceInterview process: Initial 1:1 Phone Interview with Hiring Manager Group Interview with CORE SMEsWe invite qualified candidates to send your resume to .