We are searching for an Automation Engineer to work second shift with experience in pharmaceutical drug product manufacturing. At a new fill-finish facility in Petersburg, VA, we are dedicated to manufacturing and supplying 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.
JOB RESPONSIBILITIES
Work with SCADA Systems: Preferably Rockwell's FactoryTalk View.
PLC & HMI Troubleshooting: Work with Rockwell and HMI systems to resolve control issues.
Rockwell Software Support: Maintain systems like Data Historian, AssetCentre, and FactoryTalk Directory.
Issue Resolution: Troubleshoot daily issues and mentor junior engineers.
Control Systems Knowledge: Strong grasp of control system standards, instrumentation, programming, and design in a cGMP setting.
Documentation: Develop specs, SOPs, test scripts, and standards.
Cross-Functional Collaboration: Work with different teams and clients to meet goals.
Self-Motivated & Organized: Independent and able to multi-task in a team-oriented, fast-paced environment.
Automation Oversight: Manage process control in a GMP-regulated environment.
Change Control: Ensure automation/process changes follow change control protocols.
Root Cause Analysis: Lead investigations and troubleshooting of control system issues.
New Product/Tech Support: Perform engineering assessments and configure automation systems for new products or technologies.
Equipment Design & Testing: Design and test automation for process and packaging equipment.
Network Support: Assist in implementing new networking technologies and architecture improvements.
SKILLS REQUIRED TO GET AN INTERVIEW
Master's degree with 2+ years of Engineering/Automation experience OR Bachelor's degree with 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 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).
PREFFERED SKILLS
Experience in sterile fill-finish facility manufacturing.
Experience with regulatory inspections.
Programming Switches, Firewalls, and designing networking architecture is preferred.
ThinManager/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.