Senior Automation Engineer

Job Title: Senior Automation Engineer

Location: St.Louis, MO

Department: Engineering / Automation & Controls

We are seeking a highly skilled and experienced Senior Automation Engineer to lead the development, implementation, and support of automated systems in our nuclear medicine manufacturing facility. This role is critical in ensuring the efficiency, safety, and compliance of systems used in the production of radiopharmaceuticals. The ideal candidate will have deep expertise in industrial automation, SCADA/HMI systems, PLC programming, and GMP-regulated environments, with a strong understanding of the unique challenges in nuclear medicine manufacturing.

Key Responsibilities:

System Design & Implementation:

Lead the design, configuration, and programming of PLC-based control systems (e.g., Siemens, Allen-Bradley, GE).

Design and develop SCADA and HMI interfaces for automated equipment and process control.

Implement automation solutions for radiopharmaceutical production, cleanroom operations, material handling, filling lines, and environmental monitoring systems.

Design and integrate control systems for shielded hot cells, gloveboxes, and radiochemical synthesis units.

Project Management:

Manage automation projects from concept through validation, including user requirements (URS), functional specifications (FS), design specifications (DS), FAT/SAT, commissioning, and IQ/OQ/PQ.

Collaborate with cross-functional teams including quality, operations, IT, and radiation safety.

Interface with equipment vendors and contractors to ensure proper integration and execution of automation-related projects.

Regulatory Compliance:

Ensure all automation systems comply with FDA 21 CFR Part 11, GAMP 5, and Good Manufacturing Practices (GMP).

Support documentation efforts including validation protocols, test plans, change controls, and risk assessments.

Assist with audits and inspections by regulatory bodies (FDA, NRC, etc.), and support deviation investigations and CAPA implementation.

System Support & Optimization:

Provide advanced troubleshooting and technical support for automated systems in a 24/7 production environment.

Develop preventive maintenance strategies and oversee system lifecycle management.

Identify opportunities for process improvement, system upgrades, and cost savings while ensuring system robustness and reliability.

Required Qualifications:

Bachelor’s degree in Electrical Engineering, Control Systems Engineering, Computer Engineering, or related field.

7+ years of experience in industrial automation within a GMP-regulated or life sciences environment.

Demonstrated experience with PLC and HMI programming (e.g., Rockwell/Allen-Bradley, Siemens TIA Portal, WinCC, FactoryTalk).

Strong understanding of SCADA systems, industrial networking, and data historian systems (e.g., OSIsoft PI, Ignition).

Experience supporting automated systems in pharmaceutical, radiopharmaceutical, or nuclear settings.

Familiarity with radiation safety protocols and shielding considerations is a significant plus.

Preferred Skills and Experience:

Experience with automated radiochemistry modules, cyclotron interfaces, or isotope production systems.

Knowledge of computerized system validation (CSV) methodologies and lifecycle documentation.

Proficient with scripting languages (Python, VBA, etc.) and industrial protocols (Modbus, OPC UA, Ethernet/IP).

Working knowledge of MES and ERP systems integration (SAP, DeltaV, etc.).

PMP or equivalent project management certification is a plus.

Soft Skills:

Excellent problem-solving and analytical skills.

Strong leadership and mentorship capabilities.

Detail-oriented with a commitment to precision in a highly regulated environment.

Effective communication skills, both written and verbal, across technical and non-technical stakeholders.

Working Conditions:

Work is performed in a cleanroom and shielded radiopharmaceutical production environment.

Must be comfortable working in areas where radioactive materials are handled (training and PPE provided).

Occasional off-hours support and participation in on-call rotations may be required.