Associate QA Software Validation Engineer

bioMérieux 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.

• →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.

• 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).

• 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.

• 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.

• 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.