Staff Manufacturing Engineer Job in Raritan, New Jersey US
Ortho Clinical Diagnostics, a member of Johnson and Johnson's Family of Companies, is recruiting for a Staff Engineer - Controls, to support the manufacturing equipment in the Raritan, NJ facility.
Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.
The Staff Engineer - Controls will be responsible for supporting new and existing equipment located at the Raritan Site. The individual will plan, fund, and coordinate/lead manufacturing projects as assigned to meet all performance requirements including cost, quality, safety and environmental criteria. Responsibilities to include support for all computer based processes, design and selection of new production equipment, modifications and upgrades to existing equipment, preparation of capital estimates, generation of capital funding, control of project budgets, timely execution of new installations, equipment commissioning and validation, development and periodic review of standard operating procedures and specifications, maintenance specifications, documentation revision control, and manufacturing project scheduling and coordination.
The individual will work in direct support of the Raritan business operating units and designated project teams to support equipment. The Individual will also provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and provide subject matter expertise in identifying and correcting issues. cGMP responsibilities will be directly associated with quality system requirements of owning and managing quality events related to process and facility equipment corrective and preventive actions. There are occasional interactions with FDA and other regulatory agencies.
Qualifications
A BA/BS degree in an Engineering or related discipline is required. A minimum of 8 years of progressive experience in the pharmaceutical manufacturing, medical device manufacturing or other FDA regulated industry is required. Previous experience in engineering, operations or related background is required. Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems is required. Demonstrated skills in developing, writing, and executing cGMP based process and equipment validations is preferred.
Candidates are required to have experience and working knowledge in the following areas: PLC programming, HMI design and programming, vision systems, servo systems and automated packaging and assembly equipment. Demonstrated written and verbal communications skills are required. The ability to communicate technical objectives and content to a varied audience is required. Previous project management, six sigma training and tech transfer is preferred. Thorough knowledge of FDA and other regulatory guidance is required. Proficiency in Microsoft MS Office is required; experience using MS Project and Auto CAD is preferred. This position will require 10% travel and will be based in Raritan, NJ.
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