Overview

Position

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.

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.

Early Development

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.

Qualifications

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.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

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.