Quality Assurance Software Validation Engineer 1
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Description
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.
- 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
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).