Sr Process Engineer (Mechanical Systems) – Radioisotope Manufact

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr Process Engineer (Mechanical Systems) – Radioisotope Manufact Full Time Individual Contributor Professional Buford, GA, US 23 days ago Requisition ID: 1224

Be Part of a Mission That Matters

Join Theragenics as a Senior Process Engineer (Mechanical Systems) and help advance the future of radiopharmaceutical manufacturing. In this critical role, you'll lead the design, optimization, commissioning, and continuous improvement of manufacturing processes and mechanical systems that support the production of life‑saving radioisotope therapies. Your expertise will directly contribute to the development of innovative cancer treatments while ensuring safe, reliable, and GMP‑compliant operations. If you're passionate about engineering excellence, process innovation, and making a meaningful impact on patient care, this is your opportunity to help shape the future of healthcare.

Company Overview

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, vascular interventions, and surgical applications. The company is headquartered in Atlanta, Georgia, with facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a premier medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that improve lives.

Role Summary

As a Senior Process Engineer (Mechanical Systems), you'll play a pivotal role in designing, developing, and optimizing manufacturing processes and equipment that support radiopharmaceutical research, development, and commercial production. Working closely with Manufacturing, Chemistry, Radiation Safety, Validation, Quality Assurance, Facilities, and Process Development teams, you'll implement engineering solutions that improve process performance, maximize equipment reliability, and support the successful transfer of new technologies into GMP manufacturing environments.

Key Responsibilities

• Lead the design, procurement, installation, commissioning, qualification, and continuous improvement of fixtures, tooling, equipment, and process systems.
• Develop process flow diagrams (PFDs), Piping & Instrumentation Diagrams (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.

Qualifications & Skills Required

• Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, Bioengineering, or a related engineering discipline.
• 3-5 years of experience in fixture design, process development, process optimization, validation, or related engineering functions.
• Proficiency with CAD software such as SolidWorks for creating 3D models and 2D engineering 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 effectively within multidisciplinary teams.

Preferred Qualifications

• Experience designing and installing automated manufacturing systems or production lines.
• Experience working in highly regulated manufacturing environments, including pharmaceutical, medical device, biotechnology, or radiopharmaceutical industries.
• Knowledge of GMP manufacturing practices and validation requirements.
• Experience supporting qualification and commissioning activities for manufacturing equipment and facilities.
• Familiarity with radiopharmaceutical manufacturing or radioactive material handling environments. This position supports research laboratories, radiopharmaceutical production facilities, cleanrooms, and controlled radiation areas. The role may require entry into classified manufacturing environments and radiological areas while wearing appropriate personal protective equipment (PPE) and radiation dosimetry devices. Occasional support during equipment installations, facility shutdowns, commissioning activities, or critical manufacturing events outside of normal business hours may be required.

Why Join Us?

Develop specialized expertise in radiopharmaceutical manufacturing while working on technically challenging projects in a rapidly growing industry. Contribute to breakthrough technologies that are shaping the future of precision medicine and targeted cancer therapies. Work alongside experts in engineering, manufacturing, quality, validation, radiation safety, and process development in a highly collaborative environment.

Enjoy a comprehensive benefits package designed to support your professional success, health, and well‑being.

Purpose-Driven Work

Be part of a team dedicated to improving patient outcomes through innovative healthcare technologies that make a real difference in people's lives.

Ready to Join Us? If you're excited about engineering innovation, manufacturing excellence, and contributing to life‑changing healthcare solutions, we'd love to hear from you.