Associate QA Software Validation Engineer

BioFire Diagnostics, LLC. • Hazelwood, MO • 12h ago

Position Summary

Develops and supports the validation and lifecycle management of GxP computerized systems by authoring and executing validation documentation, conducting risk assessments, maintaining regulatory compliance, supporting investigations and change controls, and ensuring systems remain in a validated state throughout their lifecycle. Ensures GxP systems meet regulatory compliance as well as conformance to site and global procedures.

Local Position Duties

Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports.

Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements.

Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions.

Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state.

Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking.

Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance.

Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).

Author and revise validation SOPs and the Site Validation Master Plan as required.

Participate in QA oversight activities for MES, calibration, maintenance and facilities.

Reasonable, reliable attendance and punctuality is an essential job function required for this position.

Perform all work in compliance with company quality procedures and standards.

Perform other duties as assigned.

Qualifications

Required Qualifications

Bachelor degree required (Engineering, Computer Science, Life Sciences, or related field preferred), or

Education Substitution: In lieu of a Bachelor's degree, 4+ years of professional relevant experience performing validation or quality engineering duties in health care or a regulated industry will be accepted.

No previous experience required performing validation or quality engineering duties in health care or a regulated industry

Preferred Qualifications

A minimum of 1 year of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry.

Basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820.

Understanding of cGMPSs, GAMP, and basic validation/qualification concepts.

Knowledge, Skills, and Abilities (KSAs)

Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.

Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.

Written Communications - including the ability to communicate technical data in written form

Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.

Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently

Troubleshooting issues to identify and resolve problems efficiently

Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel

Must have a basic knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).

The estimated salary range for this role is between $72,100 and $91,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux's bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate's experience and will be presented in writing at the time of the offer.

In addition, bioMérieux offers a competitive Total Rewards package that may include:

· A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options

· Company-Provided Life and Accidental Death Insurance

· Short and Long-Term Disability Insurance

· Retirement Plan including a generous non-discretionary employer contribution and employer match.

· Adoption Assistance

· Wellness Programs

· Employee Assistance Program

· Commuter Benefits

· Various voluntary benefit offerings

· Discount programs

· Parental leaves

LI-US

Similar Jobs

Electrical Superintendent

Actalent • Saint Louis, MO • 5h ago

IT & Engineering

Job Title: Electrical Superintendent (GSA PER DIEM FOR ELIGIBLE CANDIDATES) Job Description The Electrical Superintendent leads all electrical construction activities for large-scale mission critical and data center proj...

5h ago

Go to Apply

Electrical Engineer PE I

ENFRA • Creve Coeur, MO • 5h ago

IT & Engineering

About Us At our Company, we blend a rich history with a forward-looking vision. With over 100 years of experience, we are a pillar of stability in the energy infrastructure industry and a leader in innovative energy solu...

5h ago

Go to Apply

Data Scientist SME

Leidos • Saint Louis, MO • 6h ago

IT & Engineering

Description Turn complex data into mission advantage. Join Leidos on the Chinook Program supporting our Intelligence Community customer and play a critical role in transforming massive, complex datasets into actionable i...

6h ago

Go to Apply

Engineering Equipment Operator

Veterans Affairs, National Cemetery Administration • Saint Louis, MO • 1d ago

IT & Engineering

Summary This position is located at the Jefferson Barracks National Cemetery in St. Louis, Missouri. Responsibilities Operates one or more @types of heavy equipment with multiple hand and foot controls, such as a backhoe...

1d ago

Go to Apply

Mechanical Engineer

Actalent • Saint Louis, MO • 1d ago

IT & Engineering

Job Title: Mechanical Engineer Job Description This role focuses on delivering high-quality mechanical engineering solutions for nuclear power plant projects by analyzing complex problems, developing effective designs, a...

1d ago

Go to Apply

Electrical Engineer

Actalent • Saint Charles, MO • 1d ago

IT & Engineering

Electrical Engineer - Panel Design 100% Remote | AutoCAD Electrical | Panel Design |$60-$70/hr | 6-Month Contract Are you an Electrical Engineer with strong panel design experience looking for a fully remote opportunity...

1d ago

Go to Apply

UX Designer - Sedgwick AI

Sedgwick • Saint Louis, MO • 1d ago

IT & Engineering

Telecommuter TN Telecommuter ID Telecommuter AR Telecommuter NE Telecommuter LA Telecommuter MO Telecommuter TX Telecommuter IN Telecommuter NV Telecommuter KY Telecommuter MS Telecommuter FL Telecommuter SC Telecommuter...

1d ago

Go to Apply

API Spring Developer

Eliassen Group • Maryland Heights, MO • 2d ago

IT & Engineering

API Spring Developer Maryland Heights, MO Type: Contract Category: Development Industry: Communications Standard Hours: Open Reference ID: JN -092026-108603 Date Posted: 09/14/2026 Shortcut: http://careers.eliassen.com/g...

2d ago

Go to Apply

Manufacturing Engineer

Leonardo DRS, Inc. • High Ridge, MO • 2d ago

IT & Engineering

Job ID: 115483 The Leonardo DRS Naval Power Systems business is a trusted provider of innovative naval gas and hybrid power systems, control technology and support solutions for the U.S. Navy and navies around the world....

2d ago

Go to Apply

Senior, Manufacturing Engineer Automation, Air Manufacturing Innovation

Nike • Saint Charles, MO • 2d ago

IT & Engineering

WHO YOU'LL WORK WITH Nike Air Manufacturing & Innovation is transforming manufacturing through automation, robotics, connected systems, and Industry 4.0 capabilities. This role reports to the Automation Engineering M...

2d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)