Biomarker Implementation Engineer

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Relocation can be provided for qualified candidates.

In this position the employee will provide the following services to support production of PET biomarkers at Siemens Healthineers manufacturing facilities:

• Provide implementation services to enable the production and testing of PET biomarkers
• Install and qualify production and quality control equipment to enable the production of biomarkers
• Implement new production processes and analytical methods used to prepare and test existing biomarkers
• Perform on-site applications training and oversight for processes and analytical methods for new and existing biomarkers
• Interface with Process Engineering, Quality, Technical Support, and Training to ensure a smooth transition during implementations along the lifecycle of supported products
• Design and develop improvements for released products, processes, and equipment used in the production and testing of PET biomarkers, including aids and optimization to increase batch success rates
• Review data generated from implementation batch productions to ensure accuracy of results
• Review, revise, and/or develop technical documentation utilized in biomarker production, quality control, and equipment maintenance
• Provide start-up services for new PET manufacturing facilities
• Provide Tier 2 biomarker technical support and compliance oversight at assigned Radiopharma sites

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Biomarker Implementation Engineer with our Implementation Team, you will be responsible to:

• Ensure site implementations have all necessary materials and equipment on site, on time, either directly or by interfacing with other departments
• Ensure quality expectations for the company are met, communicating in a timely manner issues that require input from other departments
• Issue and manage change controls, where required, in a timely manner to ensure all departments are prepared for proposed changes/implementations being initiated
• Complete assigned trainings and maintain qualifications to ensure readiness to support implementation efforts
• Assist sites in identifying failures and completing investigations on products in the implementation phase
• Assist in investigations and analysis of the most complex field problems
• Track and review performance metrics to identify equipment and process problems
• Prioritize identified problems and develop solutions to improve productivity and customer satisfaction
• Track and maintain assets (e.g., equipment, parts, tools, software, etc.)
• Participate in the design recommendations for alternatives or changes to the most complex customer specifications and/or processes to better match company products to customer needs and to improve productivity
• Assist in the interpretation and evaluation of the most complex specifications, performance characteristics or other technical data

• Production and/or analysis of 18F radiochemistry products
• Experience working with radiochemistry production platforms
• Experience troubleshooting laboratory production and analytical platforms
• Strong mechanical aptitude

• BS degree in chemistry, engineering or other science field or equivalent experience
• Minimum 3 years experience in the production of PET biomarkers or commercial operations
• Strong interpersonal, organizational, and managerial skills
• Excellent attention to detail in the execution of job responsibilities
• Ability to accomplish multiple tasks in fast-paced environments
• Up to 50% travel, as required, to perform job functions

• Experience with 18F radiochemistry is preferred; training will be provided to an otherwise well-qualified candidate
• Experience with general radiation safety and hazardous material…