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Staff Validation Engineer, QC

Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

Position Summary:

This position provides expertise in validation of instrumentation, test methods, data collection, and associated computer systems.  The role is primarily focused on QC instrumentation and systems; however, the ability to assess, plan and execute these validations may extend to other computer systems and include leadership and execution of similar projects.

 

Primary Duties:

  • Develop technology development strategy for continuous improvement of laboratory test methods, testing automation, and test data management.
  • Design, create, execute and lead the execution of validation plans and qualification activities to support the implementation of new laboratory instruments, test systems and associated computer systems.
  • Design, create, execute and lead the execution of validation plans and qualification activities to support the changes in existing test systems and associated computer systems as well as the establishment of new laboratory or other operational capability.
  • Update Site Validation documents as required including Risk Analyses (QC Test Risk Analyses).
  • Procurement, implementation and validation of chemical, microbiological or mechanical test systems.
  • Implementation and validation of computer systems for management of test data, instrument control and security requirements, and test methods

 

Supplemental Data:

This position is responsible to help select technology with the least implementation risk, develop validation strategy, and to develop and execute protocols required to validate the technology.  This position leads risk based decision making and identifies the risks and benefits when trade-off determinations are required.

 

Training, Education, and Experience: 

  • Bachelor’s degree in scientific field with 8 years of relevant experience required OR Master’s degree in scientific field with a minimum of 6 years of relevant experience preferred.
  • Able to work with scientists, analysts, equipment vendors and implementation team members in order to identify and prevent obstacles to implementation and acceptance of new technology required.
  • Experience as subject matter expert supporting regulatory inspections required.

 

Knowledge, Skills, and Abilities:

  • Understanding of validation principles, including Computerized Systems Validation (CSV) and/or Computer Software Assurance (CSA) required.
  • Understanding and implementing Good Automated Manufacturing Practices (GAMP) and GAMP categories required.
  • Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, AAMI, PDA, etc.) required. 
  • Above work completed in regulated laboratory or testing environment required.
  • Expert ability for use of software tools for data entry and analysis; advanced technical writing skills.
     

 

 

 

 

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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