Process Engineer

Role Summary

The Process Engineer identifies, designs and implements continuous improvement initiatives in a GMP environment to deliver high-quality radioligand therapy products, ensuring reliable operation of the facility and production equipment, and supporting project operations and site objectives.

Responsibilities

• Provide technical troubleshooting throughout equipment lifecycle (startup, qualification, commercial production)
• Perform investigations / deviations from an engineering perspective to enable timely closure of deviations and CAPAs
• Lead or contribute to process equipment and utility improvement projects
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed
• Write/revise engineering documents for operation of various production systems
• Ensure compliance with industrial standards and GMP guidelines
• Develop project cost estimation and value improvement review
• Perform GMP risk assessments
• Manage technical / engineering changes through site change control process
• Participate in preparation of calibration/maintenance risk assessments for new equipment
• Create/execute Design Qualification (DQ), Installation and Operational Qualification (IOQ), and Performance Qualification (PQ) protocols
• Support internal and external audits

Qualifications

• Required: B.S. degree in Chemical, Electrical, Mechanical or Nuclear Engineering, or related technical field, with 1+ years experience providing automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
• Required: Proven skills in project management and problem solving
• Required: Exceptional time management, planning, organizational, negotiating and influencing skills
• Required: Highly self-motivated with a willingness to assume responsibilities and take ownership for work
• Required: Must adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements (e.g., OSHA, FDA, EMEA, HS&E)
• Required: Proficient in MS Office, Building Management Systems, CMMS and similar GMP systems
• Required: Ability to climb ladders and lift up to 50 lbs
• Preferred: Aseptic filling line, packaging operation experience
• Desirable: Training/experience in radiochemistry or radiological safety

Skills

• Technical troubleshooting
• Process improvement
• Documentation and qualification planning
• Regulatory compliance and risk assessment
• Project management
• Communication and collaboration

Education

• B.S. in Chemical, Electrical, Mechanical or Nuclear Engineering, or related technical field