Overview
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.
Responsibilities
- 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).
- 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.
Qualifications
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.
Job Details
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Industry: Pharmaceutical Manufacturing
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Inferred from the description for this job: Medical insurance, 401(k)
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