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    Validation Engineer - Los Angeles, United States - Azzur Group

    Azzur Group
    Azzur Group Los Angeles, United States

    3 weeks ago

    Default job background
    Description

    We are looking for a Validation Engineer with a minimum of 3 years of experience who
    possesses a strong understanding of autoclave cycle development and syringe fill/finish
    principles. The ideal candidate will be responsible for developing and optimizing autoclave
    sterilization cycles forand executing qualification protocols for syringe
    sterilization processes. The role requires collaboration with cross-functional teams to ensure
    compliance with regulatory requirements and industry standards.

    Key Responsibilities:

    • Develop and optimize autoclave sterilization cycles (cycle development) ensuring compliance with regulatory requirements and industry
      standards.
    • Design and execute qualification protocols for syringe sterilization processes, including performance qualification (PQ) and process validation.
    • Conduct risk assessments and implement mitigation strategies to address potential
      sterilization process deviations or failures.
    • Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to support product development and commercial manufacturing
      activities.
    • Stay current with industry trends and best practices related to sterilization technologies and regulatory requirements.
    Qualifications:
    • Bachelor's degree in Engineering or related field; Master's degree preferred.
    • Minimum of 3 years of experience in validation engineering or related field.
    • Strong understanding of autoclave qualification and syringe fill/finish principles.
    • Experience with sterilization process optimization and validation in a pharmaceutical or medical device manufacturing environment.
    • Knowledge of regulatory requirements, including FDA and ISO standards.
    • Excellent communication and collaboration skills.
    • Ability to work effectively in a cross-functional team environment.
    Preferred Qualifications:
    • Experience with statistical analysis and validation software.
    • Six Sigma or Lean Manufacturing certification.
    • Experience with risk management tools such as FMEA.
    • Familiarity with GMP and GDP guidelines.
    #LR-KR1
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