Associate QA Software Validation Engineer

1w1 week ago

bioMérieux

Hazelwood, US · Full-time · $70,000 – $94,500

About this role

bioMérieux seeks 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 fits early-career quality or validation professionals in regulated manufacturing environments. They ensure systems maintain validated state and comply with regulatory standards.

Daily tasks include executing validation activities under guidance, developing IQ/OQ/PQ protocols, test scripts, and reports. Review URS, risk assessments, GxP evaluations, and support change control for system modifications. Perform periodic reviews to sustain compliance.

Collaborate cross-functionally on anomaly resolution, CAPAs, investigations, and QA oversight for non-product software, MES, calibration, maintenance, and facilities. Work primarily in office and manufacturing settings with occasional lab movement. Adhere to FDA 21 CFR Part 11 and site procedures.

Build hands-on experience in validation lifecycle documentation and requalifications amid fast-paced demands. Participate in continuous improvement and deviation management. Develop analytical skills in a high-integrity team focused on quality accountability.

Requirements

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
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 (preferred)
Basic knowledge of FDA 21 CFR Part 820 and Part 11, ISO 13485, cGMPs and GAMP principles (preferred)
Understanding of validation and qualification concepts (preferred)

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

Benefits

Estimated salary range between $70,000 and $94,500
Eligible for variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program