Automation Engineer II - 1st and 2nd Shift (514)

Civica Rx•Petersburg, VA

6d•Onsite

About The Position

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. As a member of the IT/OT Automation Team, the successful candidate will be required to support system automation initiatives and perform troubleshooting that requires a good understanding of analytical problem-solving techniques, project management, lifecycle management, network, and virtual environments. The position requires a good understanding of programming, design, installation, and lifecycle management of manufacturing process controls, packaging equipment, aseptic filling lines, automation, industrial networks, virtual environments, and field instrumentation technologies.

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.

Nice To Haves

Experience in sterile fill-finish facility manufacturing.
Experience with regulatory inspections.
Experience of Thin Manager and Clients
Experience of FactoryTalk Directory, FactoryTalk Asset Centre, FactoryTalk Data Historian, Factory Talk View SE & ME, and WIN911.
Experience in control projects and time management.
Experience in Change Controls and investigations.
Experience in Programming Switches, Firewalls, and designing networking architecture.
Experience in Thin Manager/Thin Clients, SQL Server design, implementation, and support.
Experience with BMS, EMS systems, OPC, ODBC, Data Historians, WIN911, as well as Chillers, Boilers, HVAC, Wastewater and other utilities systems.

Responsibilities

Support and implement Automation solutions across the facility.
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.
Effectively interact and collaborate with cross-functional departments, and clients to meet company expectations.
Support ownership and administration of process control automation in a GMP-regulated environment.
Generate and follow proper change control for any automation/process changes within the system.
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 testing of 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.