Operations Engineer

Summary: Seeking an Operations Engineer to lead reliability improvement projects and ensure compliance with regulatory standards in pharmaceutical environments.

• Requirements:

  • Bachelor's degree in Life Sciences or Engineering
  • 2+ years of experience (pharmaceutical experience preferred)
  • Strong background in deviation investigations using RCA tools
  • Knowledge of US/international regulatory guidelines for validation, documentation, and facility systems
  • Working knowledge of cGMP and aseptic environments preferred
  • Proficient with statistical tools; Lean/Six Sigma certification preferred

• Responsibilities:

  • Lead and close reliability-related improvement projects for operations and engineering
  • Manage reliability improvement initiatives and related projects
  • Author/review Change Controls and Quality Documents for product or process changes
  • Ensure compliance with FDA, EU, HC, TGA, ISO, cGMP, and other regulatory standards
  • Review equipment, cleaning, and process validations
  • Support and participate in regulatory and internal audits
  • Serve as QA contact for risk management and FMEAs
  • Investigate complaints, deviations, OOS; ensure timely root cause documentation in EQMS
  • Analyze batch data to ensure compliance and identify improvement opportunities
  • Develop, review, revise SOPs, Batch Records, OJT/OJQs, FMEAs

Pay Details: $80,000.00 to $90,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
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