Validation and Verification Engineer

bioMerieux Inc.
paid time off, paid holidays, tuition reimbursement, 401(k)
United States, Missouri, Hazelwood
595 Anglum Road (Show on map)
Dec 22, 2024
Validation and Verification Engineer Location: Hazelwood, MO, United States Position Type: Unfixed Term Job Function: Engineering Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now > A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture. Description Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10000 per calendar year Onsite cafeteria with daily food stipend Position Summary: At bioMerieux, our dedication to public health is the thread that connects everything we do. We pioneer, develop, and produce high quality in vitrodiagnostic solutions that help healthcare professionals quickly and reliably determine a pathology or the source of a contamination and provide them with crucial information for optimal patient care. Be a part of the team that is responsible for deploying and sustaining the manufacturing of this life saving equipment. You will be working in a dynamic environment with a cross functional team including engineering, production, quality assurance, purchasing, supply chain logistics, and others. If you are passionate about solving real-world problems, you will find a home among our engineers, software developers, microbiologists, and numerous other professionals working to commission, qualify, and validate manufacturing support systems, along with verifying the design of the products themselves. Primary Responsibilities: Lead verification and validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site and department initiatives. Work with multidisciplinary engineering team members to design, construct, author, and execute engineering, verification, and reliability tests and protocols. Write and execute protocols and test cases for verifications and validations. Assure validation documentation is generated, reviewed and approved in accordance to procedures. Collect and analyze data and generate reports. Support development of project documentation (FMEAs, specifications, plans). Participate in technical reviews. Support change control processes through assessment of system changes and identifying the extent of qualification or re-qualification activities as needed. Maintain configuration management documentation and support instrument prototype builds. Support instrument, PCB, and firmware troubleshooting and issue resolution. Continuously improve and update the validation program. Comply with the design control guidelines and Quality requirements within the company's regulated ISO\ FDA environment. Education, Training, and Experience: Bachelor's Degree with 3+ years of Validation, Verification, and/or Equipment Qualification experience in a manufacturing environment OR Master's Degree with 2+ years of Validation, Verification, and/or Equipment Qualification experience in a manufacturing environment also accepted Software Validation experience is desired but not required Medical Device experience is a plus Other Skills and Abilities: Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation. Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures. Experience with engineering design documentation such as drawings and schematics. Strong troubleshooting skills. Systems Engineering and integration skills with demonstrated relevant experience over the full product development cycle for a complex electromechanical system. Must be able to work independently, manage time to work on several simultaneous projects, participate on risk assessment teams, and learn/apply new verification and validation methodologies. Knowledge of electro/mechanical production processes. Technical skills in the relevant Manufacturing Engineering disciplines. Knowledge of FDA, QSR and ISO quality systems. Strong collaborative and communication skills. Exceptional attention to detail. #LI-US #biojobs Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux 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 recruitment@biomerieux.com. BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS). Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now >