Associate QA Software Validation Engineer - Biofire

Position Summary:

This position is based in the St Louis area and cannot be fully remote. 

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 conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations. Routinely 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. Responsible as a site software QA Validation Engineer to represent St. Louis when globally deployed computer systems are implemented.

Primary Responsibilities:

• 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
• Participate in CRB meetings as a non-product software QA representative.  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).
• Review and approve validation documentation ensuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
• 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.
• Reasonable, reliable attendance and punctuality is an essential job function required for this position.
• Ability to interface across multiple disciplines of the organization
• Support FDA and MDSAP Audits
• Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities. 

Education, Skills, & Experience:

• Requires a 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 utilizing Seapine TestTrack, Sparta Trackwise, MSProject, Mindjet MindManager, Rockwell Automation Factory Talk Pharma Suite 4.0, Perforce Software management, PTC Windchill are a plus.
• Medical Device or other FDA regulated industry experience 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 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 perspective.
• Proficient in Microsoft Suite

#LI-US