Sr. Process Engineer

Our client is looking for a Senior Process Engineer with a strong mechanical engineering background to support the design, optimization, commissioning, and operation of radiopharmaceutical research, development, and manufacturing processes. This role is responsible for developing and improving production systems, process equipment, and facilities to ensure safe, reliable, and GMP-compliant manufacturing of radioactive pharmaceuticals.

The successful candidate will work closely with Manufacturing, Chemistry, Radiation Safety, Validation, Quality Assurance, Process Development, and the Facilities teams to improve process performance, maximize equipment reliability, support technology transfer, and implement engineering solutions for both R&D and commercial manufacturing operations.

What you’ll do:

Lead the design, procurement, installation, commissioning, qualification, and continuous improvement of fixture, tooling, equipment and process systems.

Develop process flow diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), equipment layouts, and engineering specifications with cross functional team.

Create detailed engineering drawings, assembly models, and bills of materials (BOMs).

Support preventive and predictive maintenance strategies to maximize equipment uptime.

Collaborate with R&D teams to transition new radioisotope manufacturing processes into GMP manufacturing.

Prepare User Requirement Specifications (URS), Functional Design Specifications (FDS), and engineering documentation.

Support equipment qualification activities including (FAT, SAT, IQ, OQ, and PQ) engineering change controls and validation protocols.

Develop and maintain Standard Operating Procedures (SOPs), maintenance procedures, and engineering standards.

Provide technical support during manufacturing operations, investigations, and regulatory inspections.

What you’ll need:

Bachelor's or Master’s degree in Mechanical Engineering, Manufacturing engineering, Bioengineering or related engineering discipline.

3-5 years of experience in complex fixture design, process development and optimization, validation, etc.

Professional with CAD software such as SolidWorks to generate 3D / 2D drawings

Understanding of mechanical systems, fluid mechanics, heat transfer, and process equipment design.

Knowledge of engineering change management and document control systems.

Strong troubleshooting and root cause analysis skills.

Would be great if you had:

Experience on automation line design and installation.

Experience of working in highly regulated manufacturing environments is a plus.

Additional Information:

This position supports research laboratories, radiopharmaceutical production facilities, cleanrooms, and controlled radiation areas. Work may require entry into classified manufacturing environments and radiological areas while wearing appropriate personal protective equipment (PPE) and radiation dosimetry. Occasional support during equipment installations, facility shutdowns, and commissioning activities outside normal business hours may be required.