bioMérieux is hiring a

Quality Assurance Software Validation Engineer 1

Hazelwood, United States
Full-Time

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. 

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