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Development Engineer
1 week ago
Apex Innovations Fort Thomas, United StatesKYOCERA AVX is a global leader in the manufacturing of advanced electronic components, dedicated to accelerating technological innovations and shaping a better future. As a wholly-owned subsidiary of Kyocera Corporation, KYOCERA AVX has an extensive global presence with multiple ...
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Repair Development Engineer
3 weeks ago
Cynet Systems Cincinnati, United StatesJob Description: · Pay Range $23hr - $28hr · Responsibilities: · Conduct detailed inspections of aircraft engine departure records to identify any discrepancies or issues. · Analyze and interpret technical data, maintenance logs, and maintenance records to determine the requi ...
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Cloud Engineer/Developer
3 weeks ago
ComResource Cincinnati, United StatesJob Description · Job DescriptionComResource is looking for a Cloud Engineer / Developer. · This person will be responsible for the design, implementation, and ongoing operational efforts of the infrastructure services, server OS, MDM service, patch deployment/protection, backup ...
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Civil Engineer Land Development
2 weeks ago
Liberty Personnel Services, Inc Cincinnati, United StatesJob Description · Job DescriptionCivil Engineer Land Development · Are you a driven and innovative Civil Engineer looking for your next big challenge? Do you want to join a dynamic and growing company with a strong reputation in the industry? Our Cincinnati office is currently se ...
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Cloud Engineer/Developer III
3 weeks ago
Strategic Systems Cincinnati, United StatesTitle: Cloud Engineer/Developer III · Duration: Through 12/31/2024 · Location: Cincinnati, OH · Responsible for the design, implementation, and ongoing operational efforts of the infrastructure services, server OS, MDM service, patch deployment/protection, backup and restorati ...
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Engineer, Repair Development
4 weeks ago
StandardAero Cincinnati, United StatesRepair Development Engineer · Cincinnati, Ohio · Build an Aviation Career You're Proud Of · Explore a career where you're challenged and have access to exciting engineering projects that stretch your talents. You'll design and create new systems and technologies to help solve ...
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Repair Development Engineer
2 weeks ago
Cynet Systems Cincinnati, United StatesJob Description: · Pay Range $23hr - $28hr · Responsibilities: Conduct detailed inspections of aircraft engine departure records to identify any discrepancies or issues. · Analyze and interpret technical data, maintenance logs, and maintenance records to determine the required ...
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Phoenix Industries St. Xavier, United StatesElevating St. Xavier's technologies to the next level, tackling challenges, and working on tomorrow's innovations - that's what we need at FERCHAU from experts like you. We realize exciting projects for renowned providers and developers of IT solutions and provide comprehensive e ...
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Synchrony Cincinnati, United StatesJob Description: · Role Summary/Purpose: · The Assistant Vice President, Principal Mobile Software Development Engineer craves working in a hands-on mobile environment and leads by example to make sure projects are delivered on time and to specification. To be successful in this ...
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New Product Development Engineer
2 weeks ago
Droisys Cincinnati, United StatesLooking for Project Manager with New Product Development experience would be ideal. · Role: New Product Development Engineer · Location: Cincinnati, OH · Fulltime · Must-Have: · Bachelor's Degree in Mechanical Engineering or another relevant Engineering Degree · Previous experien ...
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Development Quality Senior Engineer
3 weeks ago
GE Aviation Cincinnati, United StatesJob Description SummaryIn this role you will be a member of the Quality Development Team as part of the larger Edison Works (EW) Engineering Delivery Team. The goal of the Quality Development Team is work with the EW production quality team, design engineering, and suppliers to p ...
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Development Quality Senior Engineer
4 weeks ago
GE Aviation Cincinnati, United StatesJob Description Summary · In this role you will be a member of the Quality Development Team as part of the larger Edison Works (EW) Engineering Delivery Team. The goal of the Quality Development Team is work with the EW production quality team, design engineering, and suppliers ...
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Civil Engineer Land Development
1 week ago
Liberty Personnel Services, Inc. Cincinnati, United StatesAre you a driven and innovative Civil Engineer looking for your next big challenge? Do you want to join a dynamic and growing company with a strong reputation in the industry? Our Cincinnati office is currently seeking a talented Civil Engineer to lead and contribute to a variety ...
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Lead Software Development Engineer
4 days ago
New Relic Cincinnati, United StatesLead Software Development Engineer, Developer Platform Team - Golang (Remote) Lead Software Development Engineer, Developer Platform Team - Golang (Remote) Lead Software Engineer Your opportunity If you are driven by innovation, passionate about technical excellence, and ready to ...
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Senior Land Development Engineer
2 weeks ago
Fishbeck, Thompson, Carr & Huber, Inc. (FTCH) Cincinnati, United StatesPosition: · Senior Land Development Engineer · Location: · Cincinnati, OH · Job Id: · 1645 · # of Openings: · 1 · Senior Civil / Land Development Engineer · Location: Michigan or Ohio Offices · Job Summary · Fishbeck has an exciting opportunity for a creative and talented ...
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CME Talent Solutions Cincinnati, United StatesEngineering Staffing Business Development Manager (BDM) · $55,000-$65,000 Base Salary + Top Tier Commission Plan · Cincinnati, OH · Hybrid work schedule · *Option for full remote after 6 months or for qualified non-local candidates · Are you searching for a rewarding opportunity ...
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SDET (Software Development Engineer in Test)
3 weeks ago
w3r Consulting Cincinnati, United StatesJob Description: As part of a cross-functional agile squads, chapter and tribe, a Software Development Engineer in Test's (SDET) primary role is to provide thought leadership within the Quality Engineering discipline as well as ensuring quality through delivery of test automation ...
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CME Talent Solutions Cincinnati, United StatesEngineering Staffing Business Development Manager (BDM) · $55,000-$65,000 Base Salary + Top Tier Commission Plan · Cincinnati, OH · Hybrid work schedule · *Option for full remote after 6 months or for qualified non-local candidates · Are you searching for a rewarding opport ...
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Radiant Technologies Kincaid, United StatesReference number: y3_1125 · Do you enjoy working on innovative and current topics in the automotive industry? Ypsilon3 is looking for a person in development engineering who wants to drive the electronic development of driver assistance systems. Tasks include exchanging with depa ...
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Process Engineer
1 week ago
Infinity Systems Inwood, United StatesAt Inwood, you can find ORAFOL products all over the world: on airplanes, cars, road signs, safety vests, and much more. Our commitment to ourselves is not only to never stand still, but to continuously develop our products. As specialists in plastic finishing, we are looking for ...
Lead Process Development Engineer - Cincinnati, United States - Aprecia Pharmaceuticals
Description
General Purpose of Position :
Fill a key role on a team of engineers and scientists tasked with the innovation and development of proprietary and non-proprietary processes and process technologies to be used in the development and manufacture of commercially viable pharmaceutical products based on additive manufacturing platforms.
Responsible for supporting the engineering and development of innovative technologies, equipment, processes, and material sets in collaboration with engineering teammates such that pharmaceutical product developers are equipped with a broad and reproducible "toolset" from which to rapidly and confidently develop commercially viable products.
Provide process expertise for the design, development, installation, and validation of Aprecia's proprietary 3DP (three-dimensional printing) technology platforms.Responsible for expanding and supporting the technology platform(s) used in Aprecia's product development programs, including development of new processes and intellectual property.
Supports general process needs including factory, site, and/or product acceptance testing of instruments, DOE or general test protocol execution, and other aspects of the development of new (or improvements to existing) pharmaceutical manufacturing equipment intended for commercial production or product development.
Generate and execute various engineering and validation documents associated with Aprecia's manufacturing equipment, ensuring that our pharmaceutical products are manufactured in a manner that accounts for efficiency, safety, quality, and efficacy.
Primary Duties and Responsibilities (Essential Functions) : Duties/Responsibilities 1 Become an operational SME (subject matter expert) on Aprecia's next generation and legacy 3DP manufacturing equipment 2 Coordinate and lead activities regarding the development of automated equipment and processes including developing operational and in process / real time testing concepts and supporting documentation, definition of specifications, risk assessments, design reviews, root cause analyses, and test plan generation and execution in partnership with Design Engineering colleagues 3 Work directly with Product Development, Technical Services, and Manufacturing colleagues to ensure new and existing processes and process technologies meet expectations for performance, flexibility, ruggedness, reproducibility, and cost efficiency 4 Operate laboratory equipment in pursuit of the development of new printing fluids, product material characterization, alternative printing/process technologies, process analytical technologies (PAT), or other engineering development focused activities 5 Collaborate with, and at times manage, technology and integration vendors to ensure projects meet specifications and are delivered on time 6 Oversee collection and statistical evaluation of process data to support / define capabilities of new equipment, in-process testing and determining critical process parameters (CPP) for continuous process improvement 7 Author and review technical memos, qualification/validation protocols and reports for cleaning and manufacture of drug product to demonstrate a state of control 8 Execute sampling and testing as needed based on protocols or test plans to support activities including validation 9 Prepare or review appropriate documentation including change control documentation, URS (user requirement specifications), scope of work documents, and operation / maintenance manuals as required for new or modifications to qualified equipment 10 Project management as delegated for technical transfer and continuous improvement efforts within Aprecia Reporting to this Position : No direct reports Travel : Position may require 0-10% travel Work Shift : This position works days Knowledge, Skills and Abilities : Working knowledge of pharmaceutical industry and cGMPs preferred Working knowledge of additive manufacturing processes preferred Strong written, verbal, and interpersonal skills Statistical analysis, data management, data visualization and presentation skills Ability to work in a hands-on collaborative fashion with many different disciplines both inside and outside of the company Experience with structured problem-solving tools and leading multi-disciplinary teams in root-cause-analyses Binder-Jet/Inkjet printing technology operational/troubleshooting experience desired Powder bed additive manufacturing operational/troubleshooting experience desired Project management and/or vendor management experience desired Ability to manage multiple projects simultaneously Ability to learn and adapt to demands in a fast paced, advanced technology development work environment Mechanical/electrical assembly, wiring, and troubleshooting capability a bonus Machining/fabrication/welding skills a bonus PLC/Controls/Programming skills a bonus Education and Experience : B.S.
degree in Engineering, Chemistry, Math or a related discipline required M.S.degree in Engineering, Chemistry, Math or a related discipline desired Minimum 5-10 years of experience in the pharmaceutical industry or additive manufacturing industry with experience in developing novel equipment, processes, technology and/or modifying existing process trains and materials to achieve novel endpoints Experience in technology development and maturation from early proof-of-concept to production scale implementation required Hands-on experience operating/troubleshooting/testing/improving manufacturing equipment required Physical Demands and Work Environment : Good eyesight to read, interpret, and create technical materials Good manual dexterity to operate computer and other general office equipment Sitting at a desk or standing for extended periods of time Occasional lifting of boxes (up to 25 pounds) containing engineering materials, manuals, tools, etc.
Exposure to odd body positions (i.e. twisted torso, bent over position, etc.) for brief periods of time while testing equipment, completing validation work in the laboratories or manufacturing areas, taking samples, documenting batch information, etc. Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, safety shoes, safety glasses, etc.)GENERAL INFORMATION :
The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies.
The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.
It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company. We are an equal employment opportunity employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
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