July 6, 2022 A Technology Blog

Job Opening for Staff Manufacturing Engineer- Raritan, NJ in Ortho Clinical Diagnostics (1001 Us Highway 202, Raritan, NJ 08869)

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Job Category : Engineering
Company Name: Ortho Clinical Diagnostics
Position Name: Staff Manufacturing Engineer- Raritan, NJ
Location : 1001 Us Highway 202, Raritan, NJ 08869
Job Description : The Career Potential Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together. Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work. The Opportunity As the company continues to grow we are seeking a Staff Manufacturing Engineer to work in our Raritan, NJ facility. In this position the Staff Manufacturing Engineer r esponsibilities are to include design and selection of new facility and production systems, 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 project scheduling and coordination to meet all performance requirements including cost, quality, maintenance, safety and environmental criteria. This position is in Raritan, NJ. The Responsibilities The individual will work in direct support of the Raritan business operating units to support equipment design and purchases, upgrades, and process improvements. Responsibilities will include developing, coordinating, documenting, and delivering equipment and upgrades with the associated regulatory and change management actions related to projects. The Individual will also provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and identifying and correcting technical issues for all production shifts, as required. The individual will manage contractors, provide maintenance staff direction on projects, and coach subordinate engineers. cGMP responsibilities will include owning and managing quality events related to process, manufacturing facility equipment issues, corrective/preventive actions, and equipment /process validations. Provide technical support and interact with regulatory agencies during site audits. Working knowledge and ability to troubleshoot industrial controls, instrumentation and systems used in Bio-Pharma processing. ​ The Individual Bachelor’s Degree in Chemical or Mechanical Engineering required. Minimum 7-10 years demonstrated hands-on engineering support in Bio Pharma, cGMP manufacturing, working with operations to trouble shoot and resolve manufacturing equipment and processing issues. Working knowledge and hands-on experience with CIP/SIP systems. Demonstrated ability to lead, write, and close-out cGMP Non-conformance and RCI investigations. Development and implement equipment/processing CAPA’s. Develop concepts and design of innovated solutions. Demonstrated ability to write and execute process and equipment validations, if required. Working knowledge of industrial controls and Bio-Pharma processing instrumentation. Ability to troubleshoot. Knowledge of FDA regulations and Regulatory guidelines. Proficient in Microsoft MS Office (Word, Excel, Project, Outlook and PowerPoint). AutoCAD and/or other CAD programs, a plus. Six Sigma Green Belt, Black Belt a plus. Demonstrated hands on application of methodologies required. Must be willing to support off-shift operations (evenings and weekends) if required. Self-guided and work independently under minimal supervision. Position located in Raritan, NJ. May require 5-10% travel at times (project dependent). EOE/AA Disability/Veteran
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