Validation Engineer II

NorthStar Medical Technologies; Beloit (WI); On-site; USD 85,000 - 125,000; Full time

Job summary

NorthStar Medical Radioisotopes is seeking a Validation Lead to drive validation lifecycle activities for GMP facilities, equipment, and computerized systems. You will plan, execute, and oversee qualification programs and technology transfers in a fast-growing radiopharmaceutical environment.

The role requires a Bachelor’s degree in Engineering or Science and at least four years in pharmaceutical validation, with hands-on experience in CSV, facility, utility, and process validation, and strong

Qualifications

• Bachelor’s degree in Engineering or a Science related field with minimum four (4) years of progressive experience in a Qualification/Validation role in the pharmaceutical industry.
• Experience with current validation principles, standard concepts, practices and procedures in a cGMP regulated environment.
• Demonstrated proficiency in three or more validation areas.

Responsibilities

• Lead validation impact assessments and oversee change management for facilities, utilities, systems, equipment, computerized systems.
• Develop site-wide Validation and Commissioning & Qualification programs including Validation Master Plans and risk-based strategies.
• Independently lead complex validation projects including commissioning, qualification, requalification, process validation, and technology transfer.
• Serve as the Validation 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, IQ/OQ/PQ protocols, and Traceability Matrices.
• Direct commissioning, qualification, and periodic review activities for GMP facilities, cleanrooms, utilities, and temperature-controlled environments.
• Provide technical guidance for process development, cleaning validation, process validation, method validation, cycle development, and commercial manufacturing operations.
• Support regulatory inspections and audits as a validation representative and ensure timely CAPA implementation.
• Drive continuous improvement of validation systems and standards through procedures, training programs, templates, and best practices.

Skills

Facility qualification

Equipment qualification

CSV

Utility qualification

Process validation

Cleaning validation

Technology transfer

Method validation

Statistics

Regulatory readiness

Education

Bachelor’s degree in Engineering or Science

Job description

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.

Essential Duties and Responsibilities

1. Lead validation impact assessments and provide technical oversight for change management activities involving facilities, utilities, systems, equipment, computerized systems, and manufacturing processes.
2. 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.
3. Independently lead complex validation projects including commissioning, qualification, requalification, process validation, and technology transfer activities with minimal supervision.
4. Serve as the Validation Subject Matter Expert (SME) for design reviews, change controls, risk assessments, investigations, deviations, CAPAs, and capital projects.
5. Lead cross-functional project teams by coordinating validation deliverables, influencing technical decisions, managing timelines, and ensuring compliance objectives are achieved.
6. 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.
7. Direct commissioning, qualification, and periodic review activities for GMP facilities, cleanrooms, utilities, temperature-controlled environments, laboratory equipment, sterilization systems, hot cells, and computerized systems.
8. Provide technical guidance for process development, cleaning validation, process validation, method validation, cycle development, and commercial manufacturing operations.
9. Support regulatory inspections and audits by serving as a validation representative, addressing observations, and ensuring timely implementation of corrective and preventive actions.
10. 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.

Minimum Education/Experience 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:

• 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.

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.