Senior Mechanical Systems Process Engineer – GMP

Theragenics Corporation; Atlanta (GA); On-site; USD 110,000 - 140,000; Full time

Job summary

Theragenics Corporation, a leader in radiopharmaceutical manufacturing, seeks a Senior Process Engineer (Mechanical Systems) to design, optimize, and transfer processes and equipment for GMP operations. You will collaborate across Manufacturing, Quality, Validation, and Process Development to enhance reliability and safety.

The role emphasizes design, qualification, and continuous improvement of mechanical systems supporting radiopharmaceutical production and research activities.

Qualifications

• Bachelor's or master's degree in Mechanical Engineering, Manufacturing Engineering, Bioengineering, or related field.
• 3–5 years of fixture design, process development, optimization, validation, or related engineering experience.
• Proficiency with CAD software such as SolidWorks for 3D/2D drawings.
• Strong understanding of mechanical systems, fluid mechanics, heat transfer, and equipment design.
• Knowledge of engineering change management and document control systems.
• Strong troubleshooting, problem-solving, and root cause analysis skills.
• Excellent written and verbal communication skills.
• Ability to collaborate with multidisciplinary teams.

Responsibilities

• Lead the design, procurement, installation, commissioning, qualification, and continuous improvement of fixtures, tooling, equipment, and process systems.
• Develop process flow diagrams (PFDs), P&IDs, equipment layouts, and engineering specifications.
• Create detailed engineering drawings, 3D models, and Bills of Materials (BOMs) using CAD software.
• Support preventive and predictive maintenance programs to maximize equipment performance and uptime.
• Partner with R&D teams to transfer new radioisotope manufacturing processes into GMP operations.
• Prepare URS, FDS, and related engineering documentation.
• Support equipment qualification activities, including FAT, SAT, IQ, OQ, and PQ protocols.
• 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

CAD SolidWorks

Mechanical systems

Fluid mechanics

Heat transfer

Problem solving

Communication skills

Team collaboration

Engineering change management

Root cause analysis

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Job description

Theragenics Corporation, a leader in radiopharmaceutical manufacturing, seeks a Senior Process Engineer (Mechanical Systems) to design, optimize, and transfer processes and equipment for GMP operations. You will collaborate across Manufacturing, Quality, Validation, and Process Development to enhance reliability and safety.

The role emphasizes design, qualification, and continuous improvement of mechanical systems supporting radiopharmaceutical production and research activities.