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.
As a Software Validation Engineer, you will oversee and support implementation of software lifecycle deliverables such as validation, change management and decommissioning, review/approve validation documentation and other computerized system lifecycle
documentation assuring conf ormance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations. In this role, you will interact with engineers, project managers, business unit owners as well as senior personnel responsible for Non-product software (NPSW) and infrastructure as they relate to St. Louis operations. You will also be the site software QA lead representing St. Louis when globally deployed computer systems are implemented.
1. Lead projects as assigned with minimal supervision by coordinating, directing, and coaching cross functional
2. Attend Non-Product Software CRB/IMP meetings and advise cross functional team members for planning
validation, change management and decommissioning of NPSW systems
3. Attend Change Advisory Board (CAB) meetings as the QA lead to represent St. Louis for implementation of
globally deployed computer systems. Support CAPA, investigations, NCs, Waivers as QA function. Revise and
update validation SOPs and Site Validation Master Plan as required.
4. Lead NPSW risk assessment efforts as needed.
5. Act as a subject matter expert on part 11 requirements and computer system validation (CSV).
6. Review and approve validation documentation ensuring conformance to site and global procedures as well as
ISO, QSR, GXP, and/or GAMP regulations.
7. Participate in NPSW change control process for system changes, re-validation, and re-qualification initiatives.
8. Support supplier and internal audit initiatives related to NPSW as needed.
9. Represent the needs of the site for globally deployed computer systems.
10. Reasonable, reliable attendance and punctuality is an essential job function required for this position.
11. Ability to interface across multiple disciplines of the organization
12. Support FDA and MDSAP Audits
13. Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.
14. May supervise and/or train associates and/or contractors as needed.
Training and Education
Requires a Bachelor’s Degree in Life Science, Computer Science, Engineering, or other equivalent discipline
8 + years of experience with Computerized System validation lifecycle
Competence in Medical Device Development Processes and/or Computer System Lifecycle validation
compliance demonstrated by relevant industry experience.
Competence in the interpretation of GXP, QSR regulations to provide guidance as appropriate for
computerized systems and automated business processes to achieve compliance.
Experience with determining priorities and resource allocation from a project site and corporation
Proficient in Microsoft Suite
Experience utilizing Seapine TestTrack, Sparta Trackwise, MSProject, Mindjet MindManager, Rockwell
Automation Factory Talk Pharma Suite 4.0, Perforce Software management, PTC Windchill are a plus.
Strong interpersonal and teamwork skills are required as this role will work globally as needed.
bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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).