Senior Quality Engineer

Location: San Francisco, CA
Department: Azzur IT, LLC

Job Description

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward. This position is currently a contract with potential for full time hire after completion.

 

Description:

  • Review and approve, as required, Validation Plans, Validation Protocols and Reports, Specifications, and Risk Assessments for Facilities, Utilities, Equipment and Instruments as required in Kite SOP-00080.
  • Administer the MVP01 Site Risk Register through the entry and assessment of Potential Risks, and the tracking and management of Active Key Risks as required in SOP-00585 and SOP-12242.
  • Support revision and approval process of MVP01 Risk Assessments.
  • Assist in the administration and execution of the Commissioning, Qualification and Validation (CQV) program for the site.
  • Liaise effectively with multiple departments to ensure that Kite Pharma computer and equipment qualification and validation activities are executed in accordance with Kite Pharma Policies and Procedures, specifically Corporate QE.
  • Proactively seek out senior collaborators to discuss potential solutions to problems. Ability to clearly present results of work, interpret data and draw conclusions.
  • Work collaboratively with cross functional departments to manage project activities
    Review technical/investigation reports as appropriate.

 

Required Education/Qualifications

 

Required Education:

  • Bachelors Degree in engineering, science, or equivalent experience

 

Preferred Education:

  • Masters Degree in engineering, science, or equivalent technical degree

 

Required Work Experience: 

  • 10+ years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
  • Experience with project management
  • Required Knowledge:
  • Strong knowledge of FDA and cGMP regulations and documentation practices
  • Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • Experience with temperature mapping
  • Expertise with many aspects of validation

 

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

 

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

 

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.

 

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.



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