Senior Manufacturing Science & Technology Engineer

Overview Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services. Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans. Position The Senior MS&T Engineer is responsible for successful internal and external manufacturing and technical transfer and operational readiness. This includes leading the development and execution of operations and maintenance procedures and other necessary documentation to ensure effective process transfer between process development and operations. The Senior MS&T Engineer is responsible for leading the development and evaluation of manufacturing processes and implementing equipment and tools for production. This position will lead the coordination of product and process improvements to meet quality and production goals. The Senior MS&T Engineer is a key role in relation to system management and performance ensuring that operating, maintenance strategies are optimized through sound decision making and planning, and continuously improved through feedback of operating experience and data. The Senior MS&T Engineer will gain an appropriate level of expertise in relation to allocated systems and equipment with an overall understanding of the drivers and limitations of system reliability and the ability to provide sound technical support, advice, and training to operations and maintenance functions. All duties and responsibilities will be done in compliance with applicable regulatory agency standards. Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination. The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders. The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing. Responsibilities Provide successful technology transfer, startup, and operation, partnering with Quality, Process Development, Engineering and Operations. When supporting operations in the CMO/CDMO business, works directly with Business Development to lead the development and execution of technical transfer plans for new products. Lead the development and execution of design transfer plans for new products and maintain process documentation for new and existing programs. Lead the preparation and execution of procedures, protocols, reports, and plans for assigned processes including factory and site acceptance testing and qualification activities in a radiological environment. Generate manufacturing batch records, recipes, workflows, and standard operating procedures, Work instructions, and logbooks, ensuring that operational data, configurations, processes, and reports meet all regulatory requirements Identify and lead efforts to improve or optimize manufacturing capacity/efficiency by analyzing and planning material and workflow, layouts/space requirements, and equipment to meet quality and production goals. Efficiently communicate to all levels of stakeholders during the process. Lead the creation and documentation of recommended maintenance strategies for relevant systems in collaboration with key stakeholders, applying risk-based decision-making practices and balancing performance, cost, and risk, including planning maintenance delivery tasks per system maintenance strategies and procedures. Lead, review, and investigate system/equipment failure incidents, formulate and record lessons learned, and continually improve and optimize system operation and maintenance strategies by implementing corrective and preventive actions. Lead and support the creation of risk assessments, gap analyses, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action and preventative action identification. Serve as a mentor to others in these processes across departments and functions. Provide production support for hot cells, automation equipment, and chemical/formulation, filling, and packaging processes in pharmaceutical clean room environments. Mentor others on these systems and equipment across departments and functions. Develop training programs and provide training on process systems and equipment. Display continuous improvement mindsets and behaviors to drive operational excellence. Qualifications Bachelor's Degree in applicable Engineering field such as Mechanical, Industrial, Chemical or Nuclear or equivalent combination of education and experience and minimum four (4) years of experience in a life science, nuclear power, food processing, or medical device industry. Preferred Experience: Strong experience with FDA regulations, cGMP regulations, and pharmaceutical industry. Working knowledge of Tech Transfer between Development and Manufacturing. Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9. Location NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford. Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation. NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.

Created: 2024-11-05