Job Description
Client is searching for an Automation Engineer on the second shift with experience in pharmaceutical drug product manufacturing. The site serves as a new fill-finish facility, dedicated to the manufacture and supply of essential generic sterile injectable medications.
As a member of the Engineering 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.
Essential Duties and Responsibilities:
We are seeking a skilled individual who thrives in a fast-paced environment to support and implement our Automation solutions across our facility. As an Automation Engineer, your job responsibilities include:
· Supervisory Control and Data Acquisition systems (SCADA), preferably Rockwell’s FactoryTalk View Systems.
· Trouble-shoot process control applications (Rockwell and Siemens PLCs) utilizing Programmable Logic Controllers (PLC) and Human Machine interface (HMI)
· Support Rockwell’s Data Historian, AssetCentre, FactoryTalk Directory, etc.
· Troubleshoot day-to-day issues and provide guidance to junior engineers.
· Good understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment.
· Development of detailed specifications, engineering documents, SOPs, test scripts, and engineering standards.
· Effectively interact and collaborate with cross-functional departments, and clients to meet company expectations.
· Independent, self-motivated, organized, able to multi-task in a dynamic environment and embrace a team-based culture that relies on collaboration for effective decision-making.
· 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.
Basic Qualifications and Capabilities:
· 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 (Preferably Electrical or Computer Engineering)
· 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)
· Knowledge of FactoryTalk Directory, FactoryTalk AssetCentre, FactoryTalk Data Historian, Factory Talk View SE & ME, and WIN911.
· Experience working with virtual environments. (ESXI version 7.0, VMware Workstation, Virtual Network Configuration).
Preferred Qualifications:
· Experience in sterile fill-finish facility manufacturing.
· Experience with regulatory inspections.
· Programming Switches, Firewalls, and designing networking architecture is preferred.
· 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 and Wastewater systems.
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