Validation Engineer II

NorthStar Medical Radioisotopes•Beloit, WI

3d•Onsite

About The Position

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.

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.

Nice To Haves

Facility and cleanroom qualification
Equipment qualification
Computer System Validation (CSV)
Utility qualification
Process validation
Cleaning validation
Technology transfer
Method validation
Experience supporting commercial manufacturing operations and technology transfers.
Experience using statistical tools and data analysis techniques for validation activities.

Responsibilities

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.