Senior Systems Engineer

1 day ago


Pittsburgh, Pennsylvania, United States K A Hamilton Associates Full time
Job Summary

We are seeking a highly skilled Senior Systems Engineer to join our team at K A Hamilton Associates. As a key member of our technical operations team, you will be responsible for managing the system lifecycle, including feature delivery, integration, modification, and maintenance.

Key Responsibilities
  • Serve as a system platform owner for multiple systems, ensuring the effective management of the system lifecycle.
  • Collaborate with process owners and system owners to ensure 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, adhering to Standard Operating Procedures (SOPs) and documentation requirements.
  • Support the delivery of application features and workflows by configuring parameters and templates to define COTS application behavior, along with developing reports.
  • Develop and execute formal testing for systems, adhering to SOPs and documentation requirements.
  • Guide and support the validation team during validation planning and qualification activities for application enhancements and upgrades.
Requirements
  • Undergraduate degree in Computer Science, Information Science, Engineering, Life Sciences, or 10+ years' experience in the above-listed responsibilities.
  • Minimum of 5+ years' experience in system administration, application configuration, and system lifecycle management.
  • Minimum of 5+ years' experience in a system and/or application administration role providing value for manufacturing or laboratory operations in Biotech, Pharmaceutical, or Medical Device manufacturing that was regulated by the FDA and subject to 21 CFR Part 11 requirements.
  • Demonstratable ability to work in collaborative and independent work situations and environments while multitasking.
  • Demonstratable effective verbal, written, and interpersonal skills.
  • Demonstratable ability to prioritize and operate proactively with minimal need for supervision.
Physical Requirements
  • Hybrid position - Must have the ability to travel on-site in Pittsburgh, PA.
  • Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours, and/or extra work hours, sometimes on short notice as required.
  • Ability to work under specific time constraints.
  • Must be able to sit at a desk, in meetings, and/or work on a computer for long or extended periods of time.
  • Visual and manual acuity for working with computers and equipment.


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