Primary Responsibilities: 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. + May supervise and/or train associates and/or contractors as needed. Experience, Knowledge, Skills, and Abilities: + Requires a Bachelor’s Degree in Life Science, Computer Science, Engineering, or other equivalent discipline and 5 years minimal experience with Computerized System validation lifecycle. + Software Quality Assurance experience highly desired. + Medical Device or other FDA regulated industry experience required. + Must possess effective written and verbal communication skills. Must be able to communicate effectively across all levels of management including executive level. + Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.). + Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.). + 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 + 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. #LI-US