Associate QA Software Validation Engineer

Position Summary

bioMerieux is seeking an Associate QA Software Validation Engineer to support computer system validation (CSV) and non-product software quality activities at the St. Louis site. This role is ideal for an early-career quality or validation professional looking to build experience in a regulated manufacturing environment.

The Associate QA Software Validation Engineer will support validation initiatives, maintain the validated state of systems, and ensure compliance with applicable regulatory and internal quality standards.

Key Responsibilities

• Execute computer system and equipment validation activities under the guidance of validation leads.
• Develop, review, and execute validation protocols (IQ/OQ/PQ), test scripts, and reports.
• Review and approve validation lifecycle documentation including URS, risk assessments, GxP and ERES assessments.
• Support change control activities, ensuring system changes are properly evaluated and validated.
• Perform periodic reviews and requalifications to maintain the validated state of computer systems and equipment.
• Participate in anomaly and deviation resolution in collaboration with cross-functional teams.
• Support site non-product software risk assessments and FDA 21 CFR Part 11 compliance activities.
• Assist with CAPAs, investigations, waivers, and continuous improvement initiatives.
• Participate in QA oversight activities related to non-product software, MES, calibration, maintenance, and facilities.
• Maintain accurate validation files and documentation in accordance with site and global procedures.
• Perform all work in compliance with company quality policies, procedures, and regulatory requirements.
• Perform other duties as assigned.

Required Qualifications

• Bachelor's degree required (Engineering, Computer Science, Life Sciences, or related field preferred), or
• 4 years of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry in lieu of degree.
• Ability to work in a regulated environment (pharmaceutical, biotechnology, medical device, or healthcare).
• Strong attention to detail and documentation skills.
• Proficiency with Microsoft Office tools (Outlook, Teams, Word, Excel).

Preferred Qualifications

• At least 1 year of computer system validation or quality engineering experience in a regulated industry.
• Basic knowledge of:
• FDA 21 CFR Part 820 and Part 11
• ISO 13485
• cGMPs and GAMP principles
• Understanding of validation and qualification concepts.

Key Competencies

• Strong written and verbal communication skills.
• Ability to manage priorities and meet deadlines in a fast-paced environment.
• Analytical thinking and problem-solving capabilities.
• Ability to work cross-functionally and collaboratively.
• High level of integrity, accountability, and attention to quality.

Working Conditions

• Primarily office and manufacturing environment.
• Ability to sit or stand for extended periods.
• Occasional movement throughout manufacturing areas and laboratories.
• Ability to lift up to 5-10 lbs.
• Minimal domestic or international travel required.

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux 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 [emailprotected].

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 (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).