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Validation Engineer II

United States - California - La VerneManufacturing Operations & Supply ChainRegular
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Description de l'emploi

Responsibilities (include but are not limited to):

  • Responsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.

  • Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.

  • Compiles and analyzes 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.

  • Develop procedures and/or protocols.

  • Coordinates contract personnel through completion of assignments.

  • Works on cross-functional project teams as required.

  • May provide day-to-day guidance and training to other validation technicians.

  • Serves as an information resource to validation technicians, contractors and vendors.

  • Resolves validation issues of moderate scope with limited direct supervision.

Requirements:

  • 4+ years of relevant experience and bachelor’s degree in engineering or physical science or related field.

  • 2+ years of relevant experience and an MS.

  • Understanding and application of validation principles, concepts, practices, and standards.

  • Working knowledge of current Good Manufacturing Practices (GMPs).

  • Experience with qualification of aseptic processing equipment primarily Isolator, Filler, Lyophilizer and Tank SIP, Dry Heat (Depyrogenation Tunnel) and Moist Heat Sterilization (Autoclaves), general temperature mapping.

  • Working knowledge of equipment and systems.

  • Working knowledge of industry practices.

  • Good verbal, written, and interpersonal communication skills are required.

  • Investigation skills.

  • Proficient in Microsoft Office applications.

  • Be able to read and interpret drawings such as blueprints, PFDs, P&IDs.