The Quality Control Automation (QCA) System Engineer III, Inc. is responsible for the technical lifecycle and day-to-day up-time of the enterprise facility environmental management systems, and/or equipment management systems, and/or calibration management systems from the operating system to the Commercial Off-The-Shelf (COTS) applications.

What You'll Be Doing:

• Serve as a system platform owner for multiple systems; e.g., responsibility for managing the system lifecycle including feature delivery, integration, modification, and maintenance.
• Responsible for working with process owners and system owners to ensure their day-to-day and long term system operational and project related expectations are met.
• Function as an application level and system level administrator as needed.
• Adhere to Standard Operating Procedures (SOPs) and documentation requirements while authoring requirement specifications, functional specifications, configuration specifications, and various testing (i.e., plan, scenarios, cases) documents.
• Support the delivery of application features and workflows by the configuration of parameters and templates to define COTS application behavior, along with developing reports.
• Adhere to Standard Operating Procedures (SOPs) and documentation requirements while developing and executing formal testing (e.g., commissioning) for systems.
• Guide and support the validation team during validation planning and qualification activities for application enhancements and upgrades.
• Create and review Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs.
• Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
• Provide 2nd level of support for applications used in manufacturing and laboratory operations as needed, including off-hours.

What You'll Need:

• Bachelor's degree required or 10 years experience
• 5 years' experience in system administration along with application configuration
• Facility environmental management systems (i.e., Building Automation Systems or Building Management Systems such as Siemens Desigo CC or Schneider Electric EcoStruxure)
• Environmental equipment management systems (i.e., temperature in monitoring in cryogenic areas (like freezers), pressure and oxygen/CO2/H2O2 monitoring systems such as Rees Scientific Centron Presidio or Beckman Coulter UVO)
• Calibration management systems (i.e., providing calibration tracking and change management for assets requiring calibration such as the Blue Mountain Regulatory Asset Management system)