CSV Engineer

2 months ago

Norwood, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The CSV Engineer will be working with be working 50% with the quality team and 50% testing, validating, and qualifying laboratory systems.
  • This position will be responsible for providing quality oversight support and guidance for qualification and validation activities related to computer system validation for LIMS, Chrome Leon, CTMS, SoftMax, PH, Empower, and Emoda systems.
  • The individual will provide QA Validation support and facilitate the development of validation plans, protocols, and summary reports for all stages of the validation of IT systems.
  • Daily, the CSV Engineer will work with quality teams, create change controls, get protocols tested, authoring scripts, and performing software validation.
  • Oversight of validation activities related to the implementation of IT systems.
  • Collaborate with system and business owners during qualification activities of IT systems.
  • dhere to regulatory guidance, policies, and procedures for qualification, and validation of IT systems.
  • QA Validation support and oversight for the development of user requirements, detailed design specifications, functional and configuration specifications, and requirements traceability matrices.
Requirements:
  • 5+ years of relevant experience in Biopharmaceutical or Pharmaceutical Industry.
  • Previous direct experience in validation, qualification, testing, mend documentation of laboratory systems.
  • 2+ years of experience with the following systems (from most to least important).
  • LIMS (lab vantage is preferred).
  • Chromeleon.
  • CTMS.
  • SoftMax.
  • PH.
  • Empower (Waters).
  • Emoda.
  • Project Management Experience (managing timelines, agenda, meeting follow ups.
  • Prior QA Validation experience.

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