Process Validation Specialist

3 weeks ago


Los Angeles, California, United States Azzur Group Full time
Process Validation Engineer

Azzur Group is a leading provider of GxP compliance and consulting services to the life science industry. We are seeking a highly skilled Process Validation Engineer to join our team of experts in pharmaceutical manufacturing.

Key Responsibilities:
  • Perform process and equipment validation activities, including data analysis and statistical principles.
  • Author validation plans and assist with the development of specifications for user requirements, functional requirements, and design requirements.
  • Leverage statistical tools and software to develop process validation strategies.
  • Ensure all qualifications and validations are performed according to regulatory and customer requirements.
  • Lead cross-functional review and implementation of documentation with clients or internal stakeholders.
  • Support Quality by Design on drugs to be transferred or developed on the site.
  • Support risk assessments and pFMEAs generations.
  • Compare results against acceptance criteria and lead the resolution of deviations.
  • Recommend to QA the release of qualified systems.
  • Validation of aseptic process and DS/DP manufacturing process.
Requirements:
  • BS in Engineering, Science, or equivalent technical degree.
  • Experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
  • Experience in design documentation, validation, quality systems, and process excellence methodologies.
  • Excellent written and verbal communication skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast-paced multitasking environment.
  • Strong working knowledge of FDA and cGMP regulations and documentation practices.
What We Offer:

Azzur Group offers a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.



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