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Sr. Validation Engineer

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

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

Position Summary:

Develops, supports and implements the commissioning, qualification, and validation activities for high throughput manufacturing formulation, filling, and capping operations. Additionally, develop, support, and implement validation initiatives as defined in site goals and objectives. Responsible for various validation tasks within the validation lifecycle (Validation types include equipment, software, cleaning, environmental, process, product, etc.). 

 

Responsibilities:

  • Executes assigned validation projects, with guidance and support from project validation lead/manager. Depending on level of seniority, employs robust validation principles and practices assuring project requirements, risk mitigation, project timelines and compliance to regulatory requirements and internal procedures are achieved.
  • Assures validation documentation is generated, reviewed and approved in accordance with documented procedures. Provides validation training to project teams as requested.
  • Responsible for creating and reviewing validation master templates, project validation master plans, and other related study or validation documentations.
  • Supports department manager to create and maintain project timelines, change control documentation and validation packages.
  • Responsible for the writing and/or reviewing of validation protocols and other related documentation, ensuring compliance of validation activities, including closure of anomalies found during validation, to the requirements of internal procedures and FDA/regulatory requirements.
  • Participates in Internal/Supplier Audits.

 

Studies and Experience:

  • Bachelors Degree in Life Sciences, Engineering, Technical or related field with 5 years of experience in position offered or as a Validation Engineer or related role.

 

Skills and Qualifications:

  • Good communication and writing skills. Knowledge and application of current validation regulations, guidance’s and processes. 
  • Ability to work as a team member on cross functional teams executing complex project implementations. Strong technical writing skills. 
  • Knowledge of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, EU, GAMP, FDA, etc.). 
  • Ability to use common software tools and to learn and apply new validation methodologies as needed on assigned projects and tasks. Six Sigma experience (Yellow Belt, Green Belt).  
  • Ability to participate on risk assessment teams. Primarily responsible for working in a team environment with some validation leadership responsibilities.

 

 

 

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

 

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