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Washington, D.C.

    Validation Engineer - Washington, United States - Tech Tammina

    Tech Tammina
    Tech Tammina Washington, United States

    1 week ago

    Default job background
    Description

    Responsibilities

  • Ensure equipment, facilities and programs are maintained in compliance.
    • Qualifications :
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • Must have CTU temperature mapping experience. Must be familiar with wireless and wired temperature mapping equipment (e.g. Kaye Validator, Ellabs)
  • Must have hands on experience with pharmaceutical equipment qualification. Temperature mapping, tube sealers and tube welders, facility and utilities qualification and experience in the qualification of cell therapy equipment a plus
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
  • Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
  • Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint, and Outlook with an extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
  • BS in Engineering or Science related discipline preferred.
  • Minimum of 5 years experience performing/supporting activities in a GMP environment.
  • Minimum of 3 years experience in bio/pharmaceutical equipment, facility or utility qualification
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