Product Manufacturing Expert
Posted on: 12 Feb 2021
Fort Detrick, MD
Job Description
General Dynamics Information Technology - Federal Civilian Division is looking for a Product Manufacturing Expert to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland areas.
In this role, the Product Manufacturing Expert will:
* Provide regulatory support for all manufacturing development and technology transfer activities, interacting with scientific staff and various regulatory agencies.
* Provide expert written reviews, briefings, and recommendations for manufacturing developmental medical products.
* Participate in meetings and provide input regarding manufacturing compliance.
* Review deliverables from outside Sponsors (comment on FDA communications/ packages, any regulatory deliverables, etc.).
* Provide expertise on manufacturing-related compliance to GMP.
* Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective results.
* Work with regulatory and quality teams to ensure that all quality and regulatory standards and requirements are implemented and maintained.
* Attend and participate in site visits.
* Participate in special projects as required.
REQUIRED QUALIFICATIONS:
* Bachelor's Degree in manufacturing, engineering, or related scientific field or the equivalent combination of education, professional training, or work experience.
* 5 years of related product manufacturing experience with medical products.
* Knowledgeable of CFRs and GMPs.
* Must be highly organized, detail oriented, and perform independently.
* Excellent written and oral communication skills.
* Must be U.S. citizen and be able to obtain a TI (Public Trust).
Scheduled Weekly Hours:
40
Travel Required:
None
T elecommuting Options:
Some Telecommuting Allowed
Work Location:
USA MD Fort Detrick
Additional Work Locations:
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.nnGDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
PI130138431
General Dynamics
Falls Church, VA
General Dynamics Corporation operates as an aerospace and defense company worldwide. It operates in five segments: Aerospace, Combat Systems, Information Technology, Mission Systems, and Marine Systems. The Aerospace segment designs, manufactures, and supports business-jet aircraft; and offers business-aviation services, including maintenance, fixed-base operation, government fleet, aircraft management, charter, and staffing services, as well as integrated aviation solutions.
The Combat Systems segment engages in the design, development, production, modernization, and sustainment of combat vehicles, weapons systems, and munitions. This segment offers wheeled combat and tactical vehicles; main battle tanks and tracked combat vehicles; weapons systems, armaments, and munitions; and maintenance, logistics support, and sustainment services. The Information Technology segment provides information technology (IT), IT infrastructure modernization, and professional services, as well as cloud, cyber, software development, systems engineering, and data analytics services and solutions.
The Mission Systems segment offers mission-critical C4ISR products and systems, such as space, intelligence, and cyber systems; ground systems and products; and naval, air, and electronic systems. The Marine Systems segment designs and builds nuclear-powered submarines, surface combatants, and auxiliary and combat-logistics ships for the United States Navy and Jones Act ships for commercial customers.
This segment provides nuclear-powered submarines; surface combatants; auxiliary and combat-logistics ships; commercial product carriers and containerships; design and engineering support services; and maintenance, modernization, and lifecycle support services, as well as repair services for navy ships. The company was incorporated in 1952 and is headquartered in Falls Church, Virginia.
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IndustryEngineering
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No. of Employees105,600
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Website
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Jobs Posted7128
