Validation Engineer II – Radiopharma Manufacturing Lead

NorthStar Medical Radioisotopes; Beloit (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

401(k) Match

Paid Holidays & PTO

Bonus Plan

Equity Incentive Program

Disability Insurance

Life Insurance & AD&D

Pet Insurance

FSA Options

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin is seeking a Validation Engineer II to lead complex validation and qualification projects across facilities, utilities, systems, and processes. You will develop risk-based strategies, prepare master plans, and ensure compliance with FDA, EMA, EU GMP, ICH, ISPE, and ISO guidance while supporting regulatory inspections and tech transfers.

This role requires a Bachelor’s degree in engineering or sciences with 4+ years in pharma validation, strong

Qualifications

• Bachelor’s degree in Engineering or a Science field with 4+ years in qualification/validation.
• Experience with current validation principles in a cGMP regulated environment (FDA/EMA/ISO).
• Proficiency in three or more validation areas (e.g., facility/cleanroom, equipment, CSV, utility, process, cleaning, tech transfer, method validation).

Responsibilities

• Lead validation impact assessments and oversight for changes to facilities, utilities, systems, equipment, and processes.
• Develop and support site-wide Validation and C&Q programs, including Master Plans and risk-based approaches.
• Independently lead complex validation projects including commissioning, qualification, requalification, process validation, and tech transfer.
• Serve as Validation SME for design reviews, change controls, risk assessments, investigations, deviations, and CAPAs.
• Coordinate cross-functional teams to deliver validation milestones on time and within regulatory expectations.
• Prepare, review, approve, and execute validation documentation (plans, risk assessments, URS, IQ/OQ/PQ, protocols, reports).
• Direct commissioning, qualification, and periodic reviews for GMP facilities, cleanrooms, and related systems.
• Provide technical guidance for process development, cleaning validation, and method validation.
• Support inspections and audits as validation representative and drive CAPA implementation.
• Drive continual improvement of validation systems through procedures, templates, and trainings.

Skills

Validation expertise

cGMP experience

Analytical data analysis

Education

Bachelor's degree in Engineering or Science

Tools

Statistical software

CSV (Computer System Validation)

Job description

NorthStar Medical Radioisotopes in Beloit, Wisconsin is seeking a Validation Engineer II to lead complex validation and qualification projects across facilities, utilities, systems, and processes. You will develop risk-based strategies, prepare master plans, and ensure compliance with FDA, EMA, EU GMP, ICH, ISPE, and ISO guidance while supporting regulatory inspections and tech transfers.

This role requires a Bachelor’s degree in engineering or sciences with 4+ years in pharma validation, strong