Biomarker Implementation Engineer

Siemens Healthineers

18h

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Relocation can be provided for qualified candidates Position Overview 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 This position may suit you best if you are familiar with what is below, and would like to do develop your career with Siemens Healthineers Production and/or analysis of 18F radiochemistry products Experience working with radiochemistry production platforms Experience troubleshooting laboratory production and analytical platforms Strong mechanical aptitude Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

Requirements

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

Nice To Haves

Experience with 18F radiochemistry is preferred; training will be provided to an otherwise well-qualified candidate
Experience with general radiation safety and hazardous material handling or similar technical experience
Experience working with complex analytical equipment such as HPLC, GC and TLC
Production and/or analysis of 18F radiochemistry products
Experience working with radiochemistry production platforms
Experience troubleshooting laboratory production and analytical platforms
Strong mechanical aptitude

Responsibilities

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
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