QC Automation System Engineer
3 weeks ago
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)
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