Senior Mechanical Process Engineer – Radiopharma Manufacturing

Theragenics Corporation

Atlanta (GA)

On-site

USD 100,000 - 135,000

Full time

7 days ago
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Job summary

Theragenics Corporation in Buford, GA is seeking a Senior Process Engineer (Mechanical Systems) to lead design, optimization, commissioning, and continuous improvement of manufacturing processes and mechanical systems for radiopharmaceutical production.

You will collaborate with Manufacturing, Chemistry, Validation, Quality Assurance, Facilities, and Process Development teams to enable safe, reliable GMP operations.

Qualifications

  • Bachelor's or Master's degree in Mechanical Engineering or related field.
  • 3–5 years in fixture design, process development, or related engineering functions.
  • Proficiency with CAD software (SolidWorks) for 3D models and drawings.
  • Strong understanding of mechanical systems, fluid dynamics, heat transfer, and equipment design.
  • Experience with engineering change management and document control systems.
  • Strong problem-solving and communication skills.

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 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

Mechanical design
Process development
Validation
Troubleshooting
Team collaboration

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks
PFDs & P&IDs

Job description

Theragenics Corporation in Buford, GA is seeking a Senior Process Engineer (Mechanical Systems) to lead design, optimization, commissioning, and continuous improvement of manufacturing processes and mechanical systems for radiopharmaceutical production.

You will collaborate with Manufacturing, Chemistry, Validation, Quality Assurance, Facilities, and Process Development teams to enable safe, reliable GMP operations.

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