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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The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance

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