Equipment and CSV QC Coordinator/TL

Role Summary

The Equipment and CSV QC Coordinator/TL coordinates and actively contributes to the qualification and maintenance of laboratory equipment, leads Computer System Validation (CSV) activities, and manages, supports and coordinates a team of equipment and digitalization specialists. The role also includes strong involvement in projects for the implementation of digital tools in the QC lab, such as digital scheduling systems and Laboratory Execution Systems (LES). This role supports laboratory operations, drives continuous improvement, ensures data integrity within the QC environment, and ensures compliance with regulatory standards.

Responsibilities

• Maintain all QC laboratory equipment, ensuring proper calibration, qualification, and preventive maintenance according to schedule.
• Oversee and actively participate to troubleshooting and resolution of equipment-related issues to minimize downtime and ensure uninterrupted laboratory operations.
• Lead Computer System Validation (CSV) activities for laboratory instruments and software, ensuring compliance with GMP, FDA, and other relevant regulations.
• Implement CAPEX Master Plan for QC equipment and highlight and anticipate obsolescence and replacement needs for both equipment and software.
• Coordinate equipment installations, upgrades, and decommissioning in collaboration with vendors and internal stakeholders.
• Develop, review, and approve equipment qualification protocols, validation plans, and related documentation.
• Train laboratory staff on equipment use, maintenance procedures, and CSV requirements.
• Monitor and report key performance indicators (KPIs) related to equipment reliability, validation status, and compliance.
• Ensure data integrity and security of electronic records generated by laboratory systems.
• Participate in audits and inspections, providing expertise on equipment and CSV topics.
• Lead and supervise projects for the implementation of digital tools in the QC lab, such as digital scheduling systems and Laboratory Execution Systems (LES), ensuring successful deployment, user training, and continuous improvement.
• Supervise, manage, and coordinate a team of equipment specialists, fostering their development and ensuring effective team performance.
• Drive continuous improvement initiatives to optimize laboratory efficiency and compliance.

Qualifications

• Master's degree in Life Sciences, Engineering, or related field.
• Proven experience in QC laboratory equipment management and Computer System Validation (CSV) within a regulated environment (pharmaceutical, biotechnology, or similar industry).
• Experience in team management or supervision is a plus.
• Strong knowledge of GMP, FDA, and other relevant regulatory requirements.
• Excellent organizational, problem-solving, and communication skills.
• Ability to lead projects and work collaboratively in cross-functional teams.
• Fluent in English (written and spoken); Working language French.
• Experience with electronic data management is highly desirable.

Skills

• Project leadership and cross-functional collaboration
• Laboratory equipment qualification and maintenance
• CSV and data integrity/program governance

Education

• Master's degree in Life Sciences, Engineering, or related field