Principal Technician IV-1855140805
Description
Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Technician to be located in Miami Lakes, FL.
Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.
Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.
This individual is expected to work under very limited to no supervision and at times independently, on assignments that are complex in nature where considerable judgment and initiative are required to solve problems and make recommendations. Provides guidance, training and direction to less seasoned employees. Applies non standard test technician duties in quality, testing, engineering, where considerable judgment and initiative is required. An essential part of this position will be to maintain the environmental chambers and perform environmental and accelerated aging testing, as well as to create and manage a system where all laboratory equipment as well as equipment components, devices and systems are maintained, in terms of their calibration, adjustments, tests, and qualification documents.
This individual is expected to follow standard operating procedures for all tasks, perform all laboratory analyses and activities in accordance with cGMP practices, internal and external regulations and policies and consistent with the laboratory and supply chain cycle time goals. This individual will perform laboratory investigations as appropriate when questionable analytical results are obtained, following internal OOS/OOT procedures.
He/she will lead the operation and maintenance of all environmental chambers (including scheduling calibration activities and repairs as needed) and will handle the performance of requested jobs for environmental conditioning and accelerated aging.
This individual will also lead the particulate testing area, including scheduling of all calibration activities of the Particle Counters and any additional validation activities needed. In addition, this individual will oversee and support the introduction and qualification of lab equipment, and will maintain equipment calibration, preventive maintenance and service plans documentation. He/she is expected to write/execute equipment and software validation protocols, as well as issue related reports and enter those documents into the Adaptiv documentation system.
This individual will actively participate in safety and environmental related projects, and in GMP’s and SOP related training and other required special activities that the company promotes to foster employee involvement and professional development. As part of the QA laboratory self-directed team, he/she will be responsible for leading major tasks for cost improvement projects, and/or efficiency improvement projects.
He/she will represent the company on technical matters in dealing with both the customer and consultants at the professional level. This individual will be expected to complete all appropriate health, safety and environmental hazard training. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.
While performing the duties of this job, the employee may work near moving mechanical parts and may be exposed to fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. Employee is required to wear special garments when working in the laboratory environment.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This description is an outline of the major recurring essential responsibilities of the job. It is not intended to be all inclusive of the work to be performed.
The Principal Technician must know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. He/she will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. He/she must promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities, and consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
Qualifications
To be considered for the role a minimum of an Associate degree or equivalent is preferred; or trade/technical schooling and at least 6 years of related experience in a chemistry/microbiology/biomedical testing laboratory environment preferably within the medical device industry. Previous/current experience in the medical device industry would be an asset.
The incumbent should have a broad knowledge of basic sample preparation techniques. Broader knowledge of analytical/microbiology techniques such as gravimetric measurements, volumetric dilutions, GC, UV-Vis, FTIR, pH meters, and others is preferred. The candidate must have the ability to read and understand complex technical documentation. Advanced computer and software skills, including proficiency in MS Office programs and associated sophisticated software is an asset. The incumbent must have the ability to read, communicate and understand English, and have strong technical writing skills, and the ability to develop and give presentations on technical topics. A thorough and in-depth understanding of regulatory requirements (GMP and ISO) is required. The ability to prioritize and manage the workload, and, as required, be able to manage shifting priorities based on critical deadlines so that production needs are always met.
This position will be based in Miami Lakes, FL.
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Primary Location:North America-United States-Florida-Miami Lakes
Organization: Cordis Corporation (6017)
Job Function: Quality Control
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