Senior Process Engineer - GMP Radiopharma (Mechanical Systems)

Theragenics Corporation; Buford (GA); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Theragenics Corporation in the Atlanta area seeks a Senior Process Engineer (Mechanical Systems) to design, develop, and optimize manufacturing processes and equipment used in radiopharmaceutical production within GMP environments.

You will work with Manufacturing, Chemistry, Radiation Safety, Validation, QA, Facilities, and Process Development teams to implement solutions that improve performance, reliability, and transfer new technologies to production.

Formación

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

Responsabilidades

• Lead 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 User Requirement Specifications (URS), Functional Design Specifications (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 activities, and regulatory inspections.
• Drive continuous improvement initiatives focused on safety, quality, efficiency, and reliability.

Conocimientos

Fixture design

Process development

Process optimization

Validation

Engineering functions

Educación

Bachelor's or Master's degree in Mechanical Engineering

Herramientas

SolidWorks

Descripción del empleo

Theragenics Corporation in the Atlanta area seeks a Senior Process Engineer (Mechanical Systems) to design, develop, and optimize manufacturing processes and equipment used in radiopharmaceutical production within GMP environments.

You will work with Manufacturing, Chemistry, Radiation Safety, Validation, QA, Facilities, and Process Development teams to implement solutions that improve performance, reliability, and transfer new technologies to production.