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Validation Specialist

5 months ago

South Plainfield, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities
  • Performs validation document generation, program management, and protocol execution activities.
  • Interface with Engineering, and end user groups to support development of life cycle documents and system requirements.
  • Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols.
  • Execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
  • Perform qualification activities according to site objectives and timelines.
  • Edit department SOPs and generate basic revisions as required.
  • Execute CAPA plans, risk assessments, investigations, and root cause analysis.
  • Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
Requirements
  • Working understanding of validation concepts and requirements.
  • Intermediate written and verbal communication skills.
  • Knowledge of cGMP.
  • Critical reasoning and decision-making skills.
  • Knowledge of validation industry and regulatory requirements.
  • Ability to work independently and participate in a team.
  • Work and time management skills.
  • Working proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
  • CAPA, GXP System Validation/21CFR Part 11.
  • Bachelor's degree preferred, preferably in Science or Engineering.