Equipment Validation Lead

3 days ago


Anaheim, United States AstrixTechnology LLC Full time
Company Overview

Astrix Technology LLC has been delivering information technology consulting, regulatory advisory services, and staffing solutions to the scientific community since 1995.

We provide scientists to a broad spectrum of scientific-based industries, including chemical, biotech, pharmaceutical, cosmetics, food science, flavors and fragrances, biomedical, consumer products, environmental, medical device, petrochemical, and clinical research.

This role is located in Anaheim, CA, and requires onsite work. The estimated salary for this position is $75,000 - $85,000 per year, depending on experience.

Key Responsibilities:

  • Lead validation programs covering equipment, processes, cleaning, and facility requirements.
  • Develop and update internal procedures to meet regulatory and quality standards.
  • Ensure thorough documentation and completion of recording forms, inspections, and procedures.
  • Work cross-functionally to facilitate accurate execution of validation activities.
  • Track and analyze data to ensure process consistency and reliability.
  • Document protocols and diagrams using electronic tools like Visio and MS Office.
  • Promote a collaborative team environment, encouraging respect, continuous improvement, and high performance.
  • Maintain compliance with company policies, safety protocols, and GMP standards, prioritizing health and safety in all activities.

Qualifications:

  • Bachelor's degree in engineering or equivalent experience.
  • Minimum of 5 years in an FDA-regulated industry, including 3+ years in direct validation.
  • Knowledgeable in GMP and regulatory guidelines for personal care and OTC products.
  • English fluency; bilingual in technical Spanish preferred.
  • Onsite work required.


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