Automation Engineer 2nd Shift
2 days ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.
Our mission is to make essential generic medications affordable and accessible to all patients. We are committed to working with health systems, manufacturers, and regulators to develop and implement innovative solutions that address the root causes of generic drug shortages.
Job DescriptionWe are seeking an experienced Automation Engineer to join our team on the second shift. The successful candidate will be responsible for supporting system automation initiatives and performing troubleshooting in a fast-paced environment.
The Automation Engineer will work closely with cross-functional departments to design, implement, and maintain automation systems that meet company expectations. This includes developing detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
The ideal candidate will have a strong understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment. Experience with SCADA systems, PLCs, and HMIs is also required.
Key Responsibilities:
- Support system automation initiatives and perform troubleshooting in a fast-paced environment.
- Design, implement, and maintain automation systems that meet company expectations.
- Develop detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
- Work closely with cross-functional departments to ensure effective collaboration and decision-making.
- Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation, and control systems.
Requirements:
- Master's degree and 2 years of Engineering/Automation experience or bachelor's degree & 4 years of Engineering/Automation experience or associate degree and 6+ years of Engineering/Automation experience.
- Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
- Knowledge and understanding of Data Integrity and how it applies to the Pharmaceutical Industry with a specific focus on guidelines from the FDA.
- Experience in a GMP environment, change control, nonconformance, corrective and preventive actions, and validation practices.
- Knowledge of systems such as Allen Bradley PLC platforms (ControlLogix and CompactLogix) Studio 5000 software.
- Knowledge of Siemens PLCs and software (TIA Portal software).
Preferred Qualifications:
- Experience in sterile fill-finish facility manufacturing.
- Experience with regulatory inspections.
- Programming Switches, Firewalls, and designing networking architecture is preferred.
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