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Validation Engineer

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Location: Saint Louis, 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:

Develop, support and implement basic validation initiatives as defined in site goals and objectives. Responsible for the coordination and documentation of validation efforts with other departments. Develop and executes equipment, material, cleaning, and process validation protocols including statistical analysis of data generated by validation studies.

 

Responsibilities:

  • Write and execute protocols and test cases for validations. Develops and executes equipment, material, cleaning, and process validation protocols including statistical analysis of data generated by validation studies and compiling relevant documentation. Lead validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site initiatives.
  • Assure validation documentation is generated, reviewed and approved in accordance to procedures.
  • Review and approve change controls for laboratory and production systems. Support change control processes through assessment of system changes, and identifying the extent of qualification or requalification activities as needed. Support CR, CAPA, investigations, NCs, Waivers as QA function.
  • Ensure validated state is maintained by performing periodic review of equipment, processes, etc.
  • Revise and update validation SOPs and Site Validation Master Plan as required.
  • Ensure all items on the requalification schedule are performed on time.
  • Continuously improve and update the validation program.
  • Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.
  • Reasonable, reliable attendance and punctuality is an essential job function required for this position.

 

Studies and Experience:

  • Requires Bachelor’s Degree in Engineering or Life Science and experience performing validation, or similar field, in a related industry. 7 years relevant experience will be accepted in lieu of degree.

 

Skills and Qualifications:

  • Requires basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Also requires understanding of cGMPs and validation / qualification concepts.
  • Must be able to identify and understand critical functions and features of equipment and systems.
  • Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new validation methodologies.
  • Requires effective technical writing and oral communication skills to interact across all levels of the organization.
  • This position is responsible to develop and execute validation protocols under defined guidelines.
  • Ability to lift 5-10lbs, travel throughout the site and within laboratories.

 

#BmxSTL

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

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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