Validation Engineer, Infrastructure Qualification

2 months ago


Philadelphia, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5.
  • Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
  • Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements.
  • May also investigate and trouble-shoot problems which occur and determine solutions.
  • Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
  • Maintains all documentation pertaining to validation.
  • Will assist in developing procedures and/or protocols.
  • Coordinates contract personnel through completion of assignments.
  • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required.
 Requirements:
  • Understanding and application of validation principles, concepts, practices, and standards. - 8+ years
  • Working knowledge of current Good Manufacturing Practices (GMPs).
  • Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments.
  • 6+ years qualifying infrastructure and OT networks.
  • Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.
  • Strong verbal, written, and interpersonal communication skills.
  • Proficient in Microsoft Office applications.
  • 6 of 8 skills match your profile - you may be a good fit.
  • Requirements added by the job poster.
  • 6+ years of work experience with Data Validation.
  • 6+ years of work experience with Infrastructure.
  • 6+ years of work experience with Data Acquisition.


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