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Validation Consultant

Company: VTI Life Sciences
Location: Boston
Posted on: January 27, 2023

Job Description:

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

Our client has begun construction of a new large-scale manufacturing facility in the Greater Boston Area. The first phase will provide the internal capacity to develop and manufacture of gene therapies for both clinical stage and approved products. We are looking for a Validation Consultant with a minimum of 5 years experience in QC laboratory systems validation to work on site at their facility on this project.

Responsibilities:

  • Attend QC planning meetings
  • Participate in different team workstreams
  • Validation position - field work of Class C QC equipment
  • Perform Data Integrity assessment
  • Generate and execute Validation protocols, trace matrix and specifications documents.
  • Routinely assist vendors and coordinate schedules.
  • Demonstrate general knowledge of standard manufacturing practices and equipment.
  • Strict adherence to current good manufacturing practices, standard operating procedures, and QC documentation. Help to establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data
  • Monitor QC operations to ensure compliance with specifications
  • Assist in the investigation of procedural deviations
  • Practice safe work habits and adhere to safety procedures and guidelines
  • Utilize knowledge to improve operational efficiency
  • Other duties as assigned
    Requirements:
    • +5 Years GMP experience validating QC Instrument
    • Ambitious and self-starting attitude to take on responsibilities and own process improvements
    • Proven track record of success in a fast-paced QC environment at a biotech/pharmaceutical company preferably in GMP or GLP
    • Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
    • Exceptional written, oral communication, and organizational skills required independently and with strategic collaborators
    • Ability to lead projects
    • Strong understanding of USP 1058, GAMP and Part 11
      VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

      As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org

Keywords: VTI Life Sciences, Boston , Validation Consultant, Professions , Boston, Massachusetts

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