Senior Process Engineer, Mechanical Systems — GMP Radiopharma

Theragenics Corporation; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

Theragenics Corporation in Buford, GA, is seeking a Senior Process Engineer (Mechanical Systems) to design, optimize, and commission manufacturing processes and equipment for radiopharmaceutical production within GMP environments.

You will collaborate with Manufacturing, Chemistry, Radiation Safety, Validation, QA, Facilities, and Process Development to improve performance, reliability, and transfer new technologies to production; the role emphasizes safety, quality, and regulatory readiness.

Qualifications

• Bachelors or Masters in Mechanical/Manufacturing/Bioengineering or related field.
• 3–5 years in fixture design, process development, validation, or related functions.
• Proficiency with SolidWorks for 3D modeling and drawings.
• Strong knowledge of mechanical systems, fluid dynamics, heat transfer, and process equipment design.
• Experience with engineering change management and document control systems.

Responsibilities

• Lead design, procurement, installation, commissioning, qualification, and ongoing improvement of fixtures and process systems.
• Develop PFDs, P&IDs, equipment layouts, and specifications.
• Create detailed engineering drawings, 3D models, and BOMs using CAD software.
• Support preventive and predictive maintenance programs to maximize equipment performance and uptime.
• Partner with R&D to transfer new radioisotope manufacturing processes into commercial GMP operations.
• Prepare URS, FDS, and related engineering documentation.
• Support equipment qualification activities (FAT, SAT, IQ, OQ, PQ).
• Manage engineering change controls and contribute to validation activities.
• Develop and maintain SOPs, maintenance procedures, and engineering standards.
• Provide technical support for manufacturing operations, investigations, troubleshooting, and regulatory inspections.
• Drive continuous improvement initiatives focused on safety, quality, efficiency, and reliability.

Skills

Fixture design

Process development

Process optimization

Validation

Root cause analysis

Documentation

Cross-functional collaboration

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Job description

Theragenics Corporation in Buford, GA, is seeking a Senior Process Engineer (Mechanical Systems) to design, optimize, and commission manufacturing processes and equipment for radiopharmaceutical production within GMP environments.

You will collaborate with Manufacturing, Chemistry, Radiation Safety, Validation, QA, Facilities, and Process Development to improve performance, reliability, and transfer new technologies to production; the role emphasizes safety, quality, and regulatory readiness.