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Validations Specialist - Commissioning and Qualification

San Diego, CA 92121

Posted: 01/13/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 535455 Pay Rate: 94.43 Is job remote?: No Country: United States

Job Description

  • Reports on progress and roadblocks to the project team.
  • Develop relevant protocols, execute protocols, and own C&Q activities for the decommissioning project for the commercial QC lab in San Diego
  • Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and end of life periodic reviews
  • Liaise with client end user groups to ensure project is successfully completed per industry and internal guidelines.
  • Validation using risk-based approach (FMEA, PHA, etc.)
  • Authors and reviews project documentation, as needed. (URS, FRS, Technical Specifications, Functional Specifications)
  • Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information
  • Partners with Quality to ensure a quality and compliant environment
  • Other related duties as assigned.

  • Bachelors degree in Engineering, Science or related technical field.
  • 4+ years of experience in pharmaceutical or biotechnology GMP manufacturing performing commissioning and qualification (C&Q) or equipment validation activities.
  • Ability to read/interpret engineering drawings and design documents
  • Excellent technical writing and verbal communication skills
  • Must be able to work independently and successfully plan to
  • Must be people oriented and a team player
  • Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio
  • In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211
  • Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements

Pay ranges between $60-90/hr **salary will be commensurate with experience**
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