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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.
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 II, your job responsibilities include:
• Supervisory Control and Data Acquisition systems (SCADA), preferably Rockwell's FactoryTalk View Systems and Siemens.
• Trouble-shoot 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.
• 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 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.
• Candidates must have hands-on knowledge of at least one major PLC platform: Allen Bradley PLCs (ControlLogix or CompactLogix) Studio 5000 software, or Siemens PLCs (TIA Portal).
• Candidates must have 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.
Preferred Qualifications:
• 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.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be provided to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; crouch; and reach with hands and arms and access areas with restricted space. The employee is occasionally required to conduct work activities (troubleshooting & installations) in confined spaces following safety guidelines and procedures. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Work requires occasional after-hours and weekends engineering coverage.
The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.