Automation Engineer II: Pharma Automation & Data Integrity

NorthStar Medical Technologies; Beloit (WI); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

NorthStar Medical Radioisotopes in Beloit, WI, is seeking an Automation Engineer to design, code, test, and document PLC, HMI, and DCS systems for GMP production. You will support new designs and maintain existing production controls in a fast-growing radiopharmaceutical environment.

A Bachelor’s degree in Engineering and 3+ years in automation or process control are required; Siemens TIA experience and familiarity with regulatory standards such as 21 CFR Part 11 preferred.

Qualifications

• Bachelor’s degree in Engineering and minimum three years in Automation/Process Control, or equivalent mix of education and experience.
• Knowledge of automation hardware design and maintenance; Siemens experience preferred in a regulated pharma/medical device setting.

Responsibilities

• Design, revise and commission PLC, HMI, and DCS based automation systems with input from cross-functional teams and senior staff.
• Design, code, test, debug and document programs and systems for new designs and current production systems.
• Implement automation changes to existing control system hardware and software, supervise vendor work, and develop specs and test docs.
• Create, modify and maintain automation system documentation in a cGMP state.
• Troubleshoot automation systems and train operations personnel on automated operations.
• Ensure maintenance and availability of automation system controls and equipment.
• Provide automation knowledge for troubleshooting, investigations and training related to software and hardware.
• Support validation of automation systems per cGMP and regulatory guidance.
• Develop data interfaces for data acquisition, integrity and retention, including 21 CFR Part 11 compliance.
• Understand electrical schematics, P&ID drawings and system integration (Siemens TIA) and NFPA/UL/CE/NEC requirements.
• Contribute to process risk reviews and modify equipment/designs to ensure safe operation.

Skills

PLC

HMI

DCS

Siemens TIA

Electrical schematics

P&ID drawings

21 CFR Part 11

Regulatory knowledge

Mentoring

Training

Education

Bachelor's degree in Engineering

Tools

Siemens TIA Portal

Siemens automation products

Job description

NorthStar Medical Radioisotopes in Beloit, WI, is seeking an Automation Engineer to design, code, test, and document PLC, HMI, and DCS systems for GMP production. You will support new designs and maintain existing production controls in a fast-growing radiopharmaceutical environment.

A Bachelor’s degree in Engineering and 3+ years in automation or process control are required; Siemens TIA experience and familiarity with regulatory standards such as 21 CFR Part 11 preferred.