Molecular Diagnostics Software and Equipment Specialist

Core Responsibilities

• Lead the maintenance, troubleshooting, and performance optimization of molecular software and equipment, ensuring operational efficiency
• Manage the Molecular Equipment Log and cold storage systems to support equipment life-cycle management
• Collaborate with the molecular operations team, biomedical team, and external vendors to ensure timely resolution of software and equipment issues to minimize operational downtime
• Train operators on the proper utilization and maintenance of molecular software and equipment, ensuring smooth and efficient functionality throughout the laboratory
• Support the validation, implementation, IQOQPQ, and integration of new software and equipment and advanced technologies into existing workflows
• Aid the Molecular Technical Writer in creating and maintaining procedures and other relevant documentation to support laboratory operations changes and maintenance
• Evaluate the feasibility of new instruments and software and provide strategic recommendations for adoption
• Assist with automation system troubleshooting, maintenance, and optimization to drive continuous improvements
• Ensure compliance with safety standards and conduct regular audits and quality checks on software and equipment performance
• Maintain accurate records of equipment quality control activities and collaborate with the Molecular Quality Team to prepare for regulatory audits
• Act as the primary point of contact for software and equipment-related activities, ensuring accuracy through GDP verifications and facilitating MasterControl routing to maintain compliance with regulatory standards

Qualifications

• Bachelor’s degree in Scientific or Technical Discipline or equivalent work experience required; Master’s degree preferred
• 3 or more years of experience in a molecular laboratory, IT, or technical support role required
• Automation System Certified preferred
• Certification in Coding Language preferred
• Demonstrate familiarity with molecular laboratory software, equipment, and automation systems, especially Hamilton Robotics, qPCR instruments, and sequencing instruments
• Maintain a basic understanding of molecular laboratory and/or analytical techniques
• Understand CAP/CLIA and FDA (GCP or GLP as appropriate) requirements