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Software Validation Engineer-Quality

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

 

 

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.

#biojobs

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].

BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. 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 BioMérieux’s or its affiliates’ 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).

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