Associate QA Software Validation Engineer

bioMerieux Inc.; Hazelwood (MO); On-site; USD 72,000 - 91,000; Full time

Benefits offered by this job

Medical, dental, vision plans

Life Insurance

Disability Insurance

Retirement Plan

Adoption Assistance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Discount Programs

Parental Leave

Job summary

BioMerieux Inc. in Hazelwood, MO, is seeking a professional to develop and maintain validation documentation for GxP computerized systems, ensuring compliance with FDA and EU requirements throughout the system lifecycle.

You will perform risk assessments, author URS/FRS, investigate validation anomalies, conduct requalifications, and support QA oversight of MES, calibration, maintenance and facilities, emphasizing accuracy and regulatory alignment.

Qualifications

• Bachelor's degree in engineering, CS, life sciences, or related field, or 4+ years of relevant validation/quality experience.
• No prior validation experience required, but considered a plus.
• Understanding of regulatory requirements (FDA 21 CFR Part 11, ISO 13485) is beneficial.

Responsibilities

• Author, execute, and maintain validation lifecycle documentation for GxP computerized systems.
• Perform risk assessments (FMEA) and data integrity evaluations (21 CFR 11, EU Annex 11).
• Investigate validation anomalies and support CAPA implementation.
• Conduct periodic reviews and requalifications of site/R&D systems.
• Maintain site computer system records and validation tracking.
• Peer review validation test documentation for accuracy and compliance.
• Develop URS and FRS as part of validation.
• Author and revise validation SOPs and Site Validation Master Plan.
• Support QA oversight for MES, calibration, maintenance, and facilities.
• Attend with reliability and punctuality as essential duties.
• Ensure work complies with company quality procedures.
• Perform other duties as assigned.

Skills

Critical thinking

Time management

Communication

Problem-solving

Education

Bachelor's degree in engineering, CS or life sciences

4+ years experience can substitute for degree

Tools

MS Office

Validation tools

Job description

Description

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

1. Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports.
2. Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements.
3. Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions.
4. Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state.
5. Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking.
6. Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance.
7. Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
8. Author and revise validation SOPs and the Site Validation Master Plan as required.
9. Participate in QA oversight activities for MES, calibration, maintenance and facilities.
10. Reasonable, reliable attendance and punctuality is an essential job function required for this position.
11. Perform all work in compliance with company quality procedures and standards.
12. 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 bioMerieux 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.).

Salary and Benefits

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.

• *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

BioMerieux 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 BioMerieux's or its affiliates' application process by contacting us via telephone at [phone], by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).