Sr. Quality Engineer

Company Overview

At our company, we are passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what is possible, ensuring a brighter future for patients everywhere.

Senior Quality Engineer – responsible for ensuring radioisotope production and development activities comply with FDA regulations (21 CFR Parts 210, 211, 212), ISO quality system standards, and internal quality policies. Collaborates across radiochemistry, cyclotron operations, engineering, regulatory affairs, health physics, and manufacturing teams to maintain compliance and drive continuous improvement.

• Ensure compliance with 21 CFR Parts 210 and 211 (C‑GMP for finished pharmaceuticals) and/or 21 CFR Part 212 (C‑GMP for PET drugs) where applicable to radioisotope production activities.
• Support implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements, including documentation control, deviation management, CAPA, and change control.
• Provide quality oversight for radioisotope production, purification, packaging, and distribution processes to ensure compliance with regulatory expectations and internal procedures.
• Participate in internal audits and regulatory inspections, including preparation of documentation and responses to regulatory observations.

• Develop, review, and approve SOPs, batch production records, validation protocols, qualification documentation, and technical reports supporting radioisotope production.
• Ensure production and development documentation complies with data integrity and record‑keeping requirements defined in 21 CFR 211 Subpart J.
• Support development and maintenance of master batch records and production documentation for isotope production processes.

• Lead or support validation and qualification activities for radioisotope production processes in accordance with 21 CFR 211.100 and 211.110 requirements for process validation and in‑process controls.
• Develop and execute validation protocols for equipment, manufacturing processes, and analytical methods.
• Support qualification of production equipment, hot‑cell systems, and laboratory instrumentation used in isotope processing.
• Generate and review validation reports to ensure compliance with regulatory expectations.
• Provide quality input into the preparation and maintenance of Drug Master Files (DMFs) and other regulatory submissions associated with radioisotope production and supply.

• Provide quality input into the preparation and maintenance of DMFs and other regulatory submissions associated with radioisotope production and supply.
• Conduct risk assessments and hazard analyses to support development and production activities involving radioactive materials.
• Investigate deviations, nonconformances, and out‑of‑specification events related to radioisotope production processes.
• Perform root‑cause analysis and implement corrective and preventive actions (CAPA) to maintain compliance and product quality.

• Work closely with radiochemistry and cyclotron operations teams to support development and scale‑up of new isotope production processes.
• Provide quality oversight during technology transfer from research and development to commercial production.
• Support continuous improvement initiatives related to process robustness, compliance, and operational efficiency.

Education

• Bachelor's degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field.

Experience

• Minimum 5 years of experience in quality engineering, quality assurance, or validation within regulated environments.
• Experience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials is required.
• Experience supporting DMF submissions or pharmaceutical regulatory filings preferred.
• Experience supporting process validation, equipment qualification, and GMP documentation.

Knowledge & Skills

• Strong knowledge of cGMP…