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Location: Saint Louis, 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.
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 providing validation guidance to all levels for quality assurance, compliance and continuous quality improvement. Ensure products are developed, manufactured, tested and delivered according to established procedures that will assure they meet all validation requirements. Develop and execute equipment, material, cleaning and process validation protocols including statistical analysis of data generated by validation studies.
1.Coordinate and document validation efforts with other work groups including Engineering, QC and R&D acting as the primary validation interface between Engineering and QA. 2.Develop and execute equipment, material, cleaning and process validation protocols including statistical analysis of data generated by validation studies and compiling relevant documentation. Assure validation documentation is generated, reviewed and approved in accordance to procedures.
3.Contribute as validation subject matter expert by sharing technical expertise across departments, mentoring individuals to ensure knowledge consistency and providing validation support to audits.
4.Identify, evaluate and manage risk by utilizing techniques such as FMEA, Fault Tree Analysis, Fishbone Diagram, HACCP, etc.
5.Integrate risk based decision making with the validation life-cycle.
6.Support Change Control Processes through assessment of system changes and execution of revalidation and/or re-qualification activities as needed.
7.Ensure validated state is maintained by performing periodic review of equipment, processes, etc.
8.Review and approve engineering specification documents.
Knowledge, Skills, and Abilities:
1. Requires Bachelor’s Degree in Engineering or Life Science and a minimum of seven (7) years’ experience performing primary duties in health care or a related regulated industry; or a Master’s Degree and five (5) years’ experience performing primary duties in health care or a related industry.
2 .Requires knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Knowledge of 21CFR Part 11 is a plus.
3.Must possess strong understanding of cGMPs and validation / qualification concepts.
4.Requires effective written and oral communication skills to interact across all levels of the organization.
5.Requires expert skillset of risk analysis, problem solving, statistical methods, and detail oriented technical writing.
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.