Senior Investigator, Facilities and Engineering
Senior Investigator, Facilities and Engineering
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Job Description
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 Ultragenyxs 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
#LI-CK1 #LI-Hybrid
#LI-CK1 #LI-Hybrid
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$105700 - $130600 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Senior IC
Employment Type
Full Time
