Process Validation Engineer

Location: Los Angeles, CA
Department: Azzur Consulting LLC

Job Description

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:  Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!  
What the candidate will do:    
  • Provide direct engineering support and Subject Matter Expertise for process equipment,  specifically drug product robotic fillers and grade A isolators.
  • Support development work with the small scale lab & scientists
  • Drive results by owning and completing large scope projects with challenging timelines and complex subject matter. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production capacity commitments are not impacted. 
  • The Process Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of the equipment.
  • Troubleshoot equipment to determine root cause of failure modes and independently drive failure resolution.
  • Provide input into preventative maintenance plans, calibration intervals, spare parts, and assessing Change Controls.
  • Maintain and certify Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for the GMP process equipment.
  • A bachelor’s degree in Chemical or Mechanical Engineering
  • Minimum of 3-5 years relevant experience as a Process Engineer
  • 3+ years of experience in a GxP environment preferred
  • Commissioning, qualification, and start-up experience with Process Equipment, specifically drug product robotic fillers and grade A isolators.
  • Excellent interpersonal and communication skills (verbal and written) are required.  Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.  Technical writing skills required.

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