Software Validation Engineer-Quality
bioMerieux SA Career Site - MULTI-LINGUAL
Nơi làm việc
St. Louis, MO, USA
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Toàn thời gian
Chi tiết công việc
Position Summary:
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 conformance 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.
This role works a 9/8/80 schedule-every other Friday off! You also work 2 days from home and 3 days on site!
Primary Duties
• Lead projects as assigned with minimal supervision by coordinating, directing, and coaching cross functional team members.
• Attend Non-Product Software CRB/IMP meetings and advise cross functional team members for planning validation, change management and decommissioning of NPSW systems
• 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.
• 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.
Studies and Experience:
• High School Diploma with 12+ years of experience with Computerized System validation lifecycle OR
• Bachelor's Degree with 8+ years of experience with Computerized System validation lifecycle
Skills and Qualifications:
• 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
