Senior Process Engineer (Mechanical Systems) - Radioisotope ManufactRole SummaryAs 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 & SkillsRequired Qualifications- 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.
Work EnvironmentThis 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.
