Position Summary

Develops and supports the validation and lifecycle management of GxP computerized systems by authoring and executing validation documentation, conducting risk assessments, maintaining regulatory compliance, supporting investigations and change controls, and ensuring systems remain in a validated state throughout their lifecycle. Ensures GxP systems meet regulatory compliance as well as conformance to site and global procedures.

Local Position Duties

1. Author, execute and maintain validation lifecycle documentation for GxP computerized systems including protocols, test scripts, traceability matrices, and final summary reports.
2. Perform system risk assessments (FMEA), criticality assessments and data integrity evaluations (21 CFR Part 11 and EU GMP Annex 11) to determine validation requirements.
3. Investigate validation anomalies, identify root cause and support implementation of corrective and preventative actions.
4. Conduct periodic reviews and requalifications of site and R&D computer systems to ensure they remain in a validated state.
5. Maintain site computer system records, including the site software inventory, GxP/ERES logs, and other validation tracking.
6. Perform peer reviews of computer system validation test documentation to ensure accuracy, completeness and compliance.
7. Assist in developing system requirement specifications including User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
8. Author and revise validation SOPs and the Site Validation Master Plan as required.
9. Participate in QA oversight activities for MES, calibration, maintenance and facilities.
10. Reasonable, reliable attendance and punctuality is an essential job function required for this position.
11. Perform all work in compliance with company quality procedures and standards.
12. Perform other duties as assigned.

Qualifications

Required Qualifications

• Bachelor degree required  (Engineering, Computer Science, Life Sciences, or related field preferred), or
• Education Substitution: In lieu of a Bachelor's degree, 4+ years of professional relevant experience performing validation or quality engineering duties in health care or a regulated industry will be accepted.
• No previous experience required performing validation or quality engineering duties in health care or a regulated industry

Preferred Qualifications

• A minimum of 1 year of direct computer system validation experience in the pharmaceutical, biotechnology or medical device industry.
• Basic knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820.
• Understanding of cGMPSs, GAMP, and basic validation/qualification concepts.

Knowledge, Skills, and Abilities (KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
• Written Communications - including the ability to communicate technical data in written form
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently
• Troubleshooting issues to identify and resolve problems efficiently
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
• Must have a basic knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).