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:
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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
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