Automation Engineer II - 1st and 2nd Shift (514)
BioSpace · Petersburg, VA · 3 wk ago
EngineeringFull-time
About the role
Civica is searching for an Automation Engineer II with experience in pharmaceutical drug product manufacturing. The Petersburg site serves as Civica’s new fill-finish facility, dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities
- Support and implement Automation solutions across the facility.
- Troubleshoot SCADA systems (Rockwell’s FactoryTalk View Systems and Siemens).
- Troubleshoot process control applications (Rockwell and Siemens PLCs) utilizing Programmable Logic Controllers (PLC) and Human Machine interface (HMI).
- Support Rockwell’s Data Historian, Asset Centre, FactoryTalk Directory, etc.
- Support database administration and SQL.
- Troubleshoot day-to-day issues and provide guidance to junior engineers.
- Develop detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
- Interact and collaborate with cross-functional departments and clients to meet company expectations.
- Lead root cause analysis, incident investigations, and troubleshooting on process control issues related to electrical, instrumentation and control systems.
- Support new product introductions or new technology introductions by performing engineering assessments, engineering studies, implementing automation system configuration changes, and supporting engineering runs.
- Design and test newly installed and currently installed automation-based process and packaging equipment.
- Assist in the support of network advancements and new technologies as they pertain to networking architectures.
Requirements
- Master’s degree and 6+ years of Engineering/Automation experience or bachelor’s degree & 8 years of Engineering/Automation experience or associate degree and 10+ years of Engineering/Automation experience (Preferably Electrical or Computer Engineering)
- Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
- Experience 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.
- Hands-on knowledge of at least one major PLC platform: Allen Bradley PLCs (ControlLogix or CompactLogix) Studio 5000 software, or Siemens PLCs (TIA Portal).
- Hands-on experience with at least one of the following: working in virtual environments (ESXi version 7.0, VMware Workstation, or virtual network configuration), or batch reporting.
Qualifications
- Master’s degree and 6+ years of Engineering/Automation experience or bachelor’s degree & 8 years of Engineering/Automation experience or associate degree and 10+ years of Engineering/Automation experience (Preferably Electrical or Computer Engineering)
- Familiarity with 21 CFR Part 11, Data Integrity, and GAMP 5.
- Experience 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.
- Hands-on knowledge of at least one major PLC platform: Allen Bradley PLCs (ControlLogix or CompactLogix) Studio 5000 software, or Siemens PLCs (TIA Portal).
- Hands-on experience with at least one of the following: working in virtual environments (ESXi version 7.0, VMware Workstation, or virtual network configuration), or batch reporting.