Associate QA Software Validation Engineer

Summary

bioMérieux is seeking an Associate QA Software Validation Engineer to support computer system validation 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, focusing on maintaining compliance with regulatory standards and executing validation activities.

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

Skills

• 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

Qualifications

Must Haves

• 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)

Nice to Haves

• 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

Benefits

• Variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program
• 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