Validation Engineer

3 weeks ago

Tucson, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Designs and drafts validation sampling and testing plan/protocols.
  • Executes and reports on validation studies such as Process Validation, Cleaning Validation, CSV, Commissioning, IQ, OQ and PQ studies.
  • Resolve technical issues encountered during study execution.
  • Track and expedite the review and sign-off of qualification documentation.
  • Support execution of validation activities.
  • Interact with individuals from different departments to plan, execute, and complete qualification activities.
  • Drive the completion of validation efforts according to deadlines.
  • Write / guide the writing of departmental procedures required for validation.
  • ssist during internal and 3rd party audits wrt validation requirements.
  • Initiate CAPAs, NCRs and Change Requests where required and assist with investigations.
  • ssist with identifying maintenance and calibration requirements.
  • Coordinate suppliers wrt Validation activities including obtaining quotes from suppliers.
  • Validation administration such as updating the validation plan, maintaining databases, standard referencing of documentation.
  • Review Validation plans, protocols and SOPs written by other validation team members.
  • Manage workload arising from unscheduled events.
  • Other duties as assigned by management.
  • To perform this job successfully, an individual must be able to perform each responsibility satisfactorily.
  • The requirements listed below are representative of the knowledge, skills, and/or abilities required.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

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