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In this critical role, you’ll provide quality oversight and technical leadership for radioisotope development programs, process scale‑up, and commercial production operations. Your work will directly support Drug Master Files (DMFs) and pharmaceutical supply chains, ensuring compliance with cGMP and ISO standards while contributing to therapies that improve and extend lives.
Company Overview
At our company, we’re passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what’s possible, ensuring a brighter future for patients everywhere.
- Leader in minimally invasive medical devices for cancer, vascular, and surgical applications
- Headquarters in Atlanta, Georgia, with facilities in Costa Rica, Texas, and Massachusetts
- Proud operator of Arrotek, a U.S. and Ireland‑based consultancy pioneering minimally invasive solutions
Role Summary
As a Senior Quality Engineer, you’ll ensure radioisotope production and development activities comply with FDA regulations (21 CFR Parts 210, 211, and 212), ISO quality system standards, and internal quality policies. You’ll collaborate with radiochemistry, cyclotron operations, engineering, regulatory affairs, health physics, and manufacturing teams to maintain compliance and drive continuous improvement.
Key Responsibilities
- Ensure compliance with 21 CFR Parts 210 and 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) and/or 21 CFR Part 212 (Current Good Manufacturing Practice for Positron Emission Tomography 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
Documentation & Quality Oversight:
- 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 recordkeeping requirements defined in 21 CFR 211 Subpart J
- Support development and maintenance of master batch records and production documentation for isotope production processes
Process Validation & Qualification:
- 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
Drug Master Files (DMF) Support:
- Provide quality input into the preparation and maintenance of Drug Master Files (DMFs) and other regulatory submissions associated with radioisotope production and supply
Risk Management & Investigations:
- 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
Cross-functional Collaboration:
- 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
Qualifications & Skills
Education:
- Bachelor’s degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field
Experience:
- A Minimum of 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 Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferred
- Experience supporting process validation, equipment qualification, and GMP documentation
Knowledge & Skills:
- Strong knowledge of cGMP and regulated quality systems (FDA, ISO, pharmaceutical, or medical device)
- Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling preferred
- Experience with risk management methodologies, deviation investigations, and CAPA systems
- Strong technical writing and documentation skills supporting regulated manufacturing environments
- Ability to translate development activities into compliant production documentation and regulatory support packages
- Strong project management and cross-functional communication skills
- Proficiency with Microsoft Office and electronic quality management systems
Work Environment
Primarily office and laboratory settings, with periodic work in radioisotope production areas involving radioactive materials. All work is conducted in accordance with radiation safety procedures and company safety policies.
Why Join Us
- Career growth opportunities in a global healthcare leader
- Work on innovative projects with real patient impact
- Collaborative, mission‑driven culture
- Competitive benefits package
- Purpose‑driven work: “We don’t just ship inventory; we deliver care.”
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