Lead Validation Engineer II – GMP & CQV Expert

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

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