Join the best radiopharmaceutical company in the world!
If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. 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.
At the forefront of NorthStar’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.
The Validation Engineer II is responsible for providing technical expertise and establishing Commissioning and Qualification (C&Q) strategies, programs, and lifecycle practices for radioactive pharmaceutical facilities, utilities, systems, equipment, processes, analytical methods, and computerized systems. The role independently leads complex validation and qualification projects, develops risk-based validation strategies, and ensures compliance with NorthStar quality requirements and applicable regulatory standards including FDA, EMA, EU GMP, ICH, ISPE, and ISO guidance.
The Validation Engineer II serves as a Subject Matter Expert (SME) and acts as the Validation Lead for major capital projects, technology transfers, process validation programs, facility expansions, and commercial manufacturing initiatives. This position works with minimal supervision, supports regulatory inspections and customer audits, and drives continuous improvement initiatives that strengthen compliance, operational efficiency, and inspection readiness.
All projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agency requirements.
Lead validation impact assessments and provide technical oversight for change management activities involving facilities, utilities, systems, equipment, computerized systems, and manufacturing processes.
Develop and support site-wide Validation and Commissioning & Qualification (C&Q) programs, including Validation Master Plans, validation strategies, and risk-based approaches to ensure regulatory compliance.
Independently lead complex validation projects including commissioning, qualification, requalification, process validation, and technology transfer activities with minimal supervision.
Serve as the Validation Subject Matter Expert (SME) for design reviews, change controls, risk assessments, investigations, deviations, CAPAs, and capital projects.
Lead cross-functional project teams by coordinating validation deliverables, influencing technical decisions, managing timelines, and ensuring compliance objectives are achieved.
Author, review, approve, and execute validation lifecycle documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, Process Validation protocols, Summary Reports, and Traceability Matrices.
Direct commissioning, qualification, and periodic review activities for GMP facilities, cleanrooms, utilities, temperature-controlled environments, laboratory equipment, sterilization systems, hot cells, and computerized systems.
Provide technical guidance for process development, cleaning validation, process validation, method validation, cycle development, and commercial manufacturing operations.
Support regulatory inspections and audits by serving as a validation representative, addressing observations, and ensuring timely implementation of corrective and preventive actions.
Drive continuous improvement of validation systems and standards through development of procedures, training programs, templates, best practices, and initiatives that enhance compliance, efficiency, and inspection readiness.
After 3 months you will:
Develop a strong understanding of NorthStar’s validation lifecycle and quality systems, including validation procedures, commissioning and qualification practices, change control processes, and regulatory expectations.
Support validation and qualification activities by assisting with protocol development, execution, documentation review, impact assessments, and validation deliverables under the guidance of senior team members.
Build relationships with cross-functional stakeholders while contributing to project teams, learning site systems and processes, and developing the technical expertise needed to independently lead validation activities.
After 6 months you will:
Lead routine validation and qualification activities with limited oversight, including protocol development, execution, impact assessments, change controls, and validation documentation for assigned systems and projects.
Serve as a trusted validation resource for cross-functional teams, providing technical input on commissioning, qualification, process validation, investigations, deviations, and risk assessments while building subject matter expertise.
Drive compliance and continuous improvement initiatives by supporting audit readiness, improving validation processes and templates, and ensuring validation activities are executed in accordance with regulatory and company requirements.
Bachelor’s degree in Engineering or a Science related field with minimum four (4) years of progressive experience in the pharmaceutical industry acting in a Qualification/Validation role; or equivalent combination of education and experience. Experience working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment is necessary. Demonstrated proficiency in three or more validation areas required.
Experience in the following areas is preferred:
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.
This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:
Personal Protective Equipment (PPE) is required and may include:
As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:
NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.
Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families 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.
At NorthStar Medical Radioisotopes, our mission is to provide patients global access to game-changing radiopharmaceuticals. We are 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.
Radiopharmaceutical therapy is increasingly important for cancer treatment, and NorthStar is expanding our industry-leading position in developing commercial-scale production technologies to meet this important healthcare need. We routinely produce the therapeutic radioisotope copper-67 (Cu-67) and are poised to be one of the first commercial-scale producers of non-carrier-added (n.c.a.) actinium-225 (Ac-225), using first-in-kind and environmentally preferable electron accelerator technology.
NorthStar’s Radiopharmaceutical Contract Development and Manufacturing Organization (CMDO/CMO) unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs.
At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities.
