Associate QA Software Validation Engineer

Biofire Diagnostics - Hazelwood, MO

Full-time - Entry Level

Remote - Hazelwood, MO

Computer and Electronic Product Manufacturing

About the position

The Associate QA Software Validation Engineer at BioFire Diagnostics, LLC is responsible for overseeing and supporting the implementation of software lifecycle deliverables, including validation, change management, and decommissioning. This role involves reviewing and approving validation documentation to ensure compliance with site and global procedures, as well as relevant regulations such as ISO, QSR, GXP, and GAMP. The engineer will interact with various stakeholders, including engineers and project managers, and represent the St. Louis site in global computer system implementations.

Responsibilities

• Oversee and support implementation of software lifecycle deliverables such as validation, change management, and decommissioning.
• Review and approve validation documentation ensuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
• Participate in projects as assigned with limited supervision.
• Attend Non-Product Software CRB/IMP meetings and advise cross-functional team members for planning validation, change management, and decommissioning of NPSW systems.
• Support CAPA, investigations, NCs, Waivers as QA function.
• Revise and update validation SOPs and Site Validation Master Plan as required.
• Lead NPSW risk assessment efforts as needed.
• Act as a subject matter expert on part 11 requirements and computer system validation (CSV).
• Participate in NPSW change control process for system changes, re-validation, and re-qualification initiatives.
• Support supplier and internal audit initiatives related to NPSW as needed.
• Represent the needs of the site for globally deployed computer systems.
• Support FDA and MDSAP Audits.
• Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.

Requirements

• Bachelor's Degree in Life Science, Computer Science, Engineering, or other equivalent discipline and 1+ years of experience with Computerized System Validation Lifecycle.
• In lieu of a degree, a High School Diploma/GED with 5+ years of experience in Computerized System Validation Lifecycle is also accepted.
• Software Quality Assurance experience highly desired.
• Experience in Medical Device or other FDA regulated industry is required.
• 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 for computerized systems and automated business processes to achieve compliance.
• Proficient in Microsoft Suite.

Nice-to-haves

• Experience utilizing Seapine TestTrack, Sparta Trackwise, MSProject, Mindjet MindManager, Rockwell Automation Factory Talk Pharma Suite 4.0, Perforce Software management, PTC Windchill.