Description Position SummaryThe 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.
The estimated salary range for this role is between $70,000 and $94,500. 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.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
• 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
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