Senior Quality Engineer

Be part of a mission that matters,join Theragenics as a Senior Quality Engineer and help drive the production of lifesaving radiopharmaceuticals used in cuttingedge cancer treatments. In this critical role, youll provide quality oversight and technical leadership for radioisotope development programs, process scaleup, 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 OverviewAt Theragenics, were passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of whats possible, ensuring a brighter future for patients everywhere.

Leader in minimally invasive medical devices for cancer, vascular, and surgical applicationsHeadquarters in Atlanta, Georgia, with facilities in Costa Rica, Texas, and MassachusettsProud operator of Arrotek, a U.S. and Irelandbased consultancy pioneering minimally invasive solutions Role SummaryAs a Senior Quality Engineer, youll 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. Youll collaborate with radiochemistry, cyclotron operations, engineering, regulatory affairs, health physics, and manufacturing teams to maintain compliance and drive continuous improvement. Key ResponsibilitiesEnsure 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 activitiesSupport implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements, including documentation control, deviation management, CAPA, and change controlProvide quality oversight for radioisotope production, purification, packaging, and distribution processes to ensure compliance with regulatory expectations and internal proceduresParticipate 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 productionEnsure production and development documentation complies with data integrity and recordkeeping requirements defined in 21 CFR 211 Subpart JSupport 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 controlsDevelop and execute validation protocols for equipment, manufacturing processes, and analytical methodsSupport qualification of production equipment, hot-cell systems, and laboratory instrumentation used in isotope processingGenerate and review validation reports to ensure compliance with regulatory expectationsProvide quality input into the preparation and maintenance of Drug Master Files (DMFs) and other regulatory submissions associated with radioisotope production and supplyDrug 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 materialsInvestigate deviations, nonconformances, and out-of-specification events related to radioisotope production processesPerform 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 processesProvide quality oversight during technology transfer from research and development to commercial productionSupport continuous improvement initiatives related to process robustness, compliance, and operational efficiency

Qualifications & Skills Education:

Bachelors 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 environmentsExperience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials strongly preferredExperience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferredExperience 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 preferredExperience with risk management methodologies, deviation investigations, and CAPA systemsStrong technical writing and documentation skills supporting regulated manufacturing environmentsAbility to translate development activities into compliant production documentation and regulatory support packagesStrong project management and cross-functional communication skillsProficiency with Microsoft Office and electronic quality management systems Work EnvironmentPrimarily 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 UsCareer growth opportunities in a global healthcare leaderWork on innovative projects with real patient impactCollaborative, missiondriven cultureCompetitive benefits packagePurposedriven work: We dont just ship inventory; we deliver care. Ready to make a difference? Apply today and be part of something extraordinary. Healthcare that is both hightech and human, with a global reach but a personal impact.

No visa sponsorship available. No relocation available.