Validation Engineer

Consulting Los Angeles, California

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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 for  and 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.

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