Computer Software Validation Engineer

4 weeks ago


Pittsburgh, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Update or create, application/software/IT use case documents and requirement specifications.
  • Define technical project scope and objectives.
  • pplication/software/IT functional specification documents.
  • Commissioning documents (i.e. unit tests, software verification tests).
  • Independently provide for the delivery of manufacturing modules for an ERP system by: o Configuration of parameters, forms, and workflows in the software to define application behavior.
  • Lead application demonstrations and work with end-users to insure user requirements are met.
  • Execute commissioning; support validation team's installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
  • Function as an application level system administrator.
  • Collaborate to produce Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs.
  • Develop reporting tools to support quality assessment.
  • Practice and stay current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
  • Coordinate activities with external consultants.
  • Monitor project progress by tracking activities; resolving problems; publishing progress reports; recommending actions.
Requirements:
  • Must maintain company quality and safety standards.
  • Must maintain company values Minimum Work Experience/Educational Requirements.
  • bility to demonstrate excellent interpersonal and communication skills, both written and verbal.
  • Bachelor's degree in Computer Science, Information Systems, or a related field of study.
  • 3+ years of experience in one or more of Applications Engineering or Configuration, Applications Delivery, Software Development, or Software Requirements Analysis.
  • 3 + years of experience in developing and delivering software solutions for an ERP system such as provided by: Sage, SAP, Oracle, Microsoft Dynamics NAV.
  • ble to demonstrate the experience to independently carry out tasks under the direction of CSA staff.
  • ble to demonstrate an understanding of FDA 21 CFR Part 11 and related regulations associated with biopharma, pharma, or medical device industries.
  • ble to demonstrate an understanding of manufacturing best practices like those described in ISPE GPGs.
  • bility to comprehend technical information related to biotech equipment, computer and network hardware, and the associated regulatory expectations relating to them.
  • bility to work under specific time constraints.


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