Senior Investigator, Facilities and Engineering

Position Summary:

As an investigator, you will participate in investigation teams to identify root causes, evaluate product and process impact, develop effective CAPAs and provide recommendations on batch disposition for deviations.  You will provide subject matter expertise on GMP facilities, utilities, equipment, and associated validation, and their impact on manufacturing processes to support deviations.

ultrainnovative – Tackle rare and dynamic challenges

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site

Responsibilities:

• Apply Ultragenyx's business processes for deviations and investigations to complex facilities, equipment, and environmental-related deviations 
• Performs thorough, detailed and timely deviation investigations and generation of high quality and timely investigation reports
• Apply the use of Root Cause Analysis (RCA) tools such as 5 Whys, Fishbone, Is-Is Not, and Scatterplot in support of investigations and deviation reports
• Develop collaborative relationships with related functions including Facilities/Engineering teams, Manufacturing Operations, Quality Assurance, MSAT, Quality Control, Validation, and Pharmaceutical Development
• Leverage process and equipment knowledge, Quality and Operational Excellence toolkits in completing thorough investigations
• Create reports and analyses related to deviation metrics  
• Support the deviation trend review process with analyses, summaries, and reports 
• Provide regular updates to investigation stakeholders
• Support and represent complex investigations to Health authorities during inspections

Requirements:

• Minimum B.S. degree in scientific field such as engineering, microbiology, chemistry or biochemistry 
• 4+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Facilities, Engineering, or Quality roles. 
• Fundamental understanding of the investigation process as it applies to GMP systems such as facilities (including HVAC and cleanroom), utilities, automated process equipment, calibrations/ maintenance, manufacturing and laboratory issues.  
• Ability to coordinate and facilitate meetings. 
• Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products. 
• Demonstrated ability to communicate technical information or complex situations to stakeholders in a concise and clear manner. 
• Technical knowledge of the processes and systems involved in the manufacturing of biologics and ATMPs.  
• Experience with or ability to learn Six Sigma / DMAIC and investigation management techniques.  
• Ability to facilitate and use structured problem solving and Root Cause Analysis tools including 5 Whys, Fishbone, Is-Is Not, Scatterplot.   
• Excellent technical writing skills. Prior experience authoring technical reports and regulatory submissions is desired. 
• Strong verbal communication skills

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