Manager, Computerized Systems
Civica Rx
- Petersburg, VA
- Permanent
- Full-time
- Manage existing LIMS and CDS systems and drive the selection, installation, testing, maintenance, training, and support of additional laboratory systems.
- Ensure the laboratory systems and data comply with the regulatory requirements, industry standards, and best practices for data integrity, security, and quality.
- Implement and monitor data integrity controls, such as user access, audit trails, backups, electronic signatures, data review, and data transfer, to ensure the laboratory data's accuracy, completeness, consistency, and availability.
- Manage the integration, validation, and maintenance of stand-alone lab instruments and ensure their compatibility and connectivity with laboratory systems and data.
- Perform system administration tasks for Empower, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc.
- Troubleshoot and resolve any issues related to Empower, such as network, database, instrument, or software problems.
- Coordinate with vendor and ensure the proper configuration, upgrade, backup, and recovery of the Empower system.
- Collaborate with cross-functional stakeholders to understand the laboratory needs and deliver computerized system solutions that enable analytical excellence and data integrity controls.
- Manage the computerized system budget for Laboratory Systems, resources, and vendors, ensuring the optimal utilization and allocation of the system assets and services.
- Cross-train to provide backup support for other Site IT needs.
- Monitor and report on the computerized system performance, risks, and issues, and implement corrective and preventive actions as needed.
- Identify and drive computerized system innovation and improvement opportunities, leveraging new technologies and methodologies.
- A bachelor’s degree in computer science, engineering, or a related field with 8+ years of experience in computerized system roles in the pharmaceutical or biotechnology industry.
- A strong knowledge of the computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc.
- A solid understanding of laboratory processes, systems, and technologies, including LIMS and CDS.
- A familiarity with the stand-alone lab instruments, their functions, and their requirements, such as calibration, qualification, and data transfer.
- Experience implementing data integrity controls.
- Proficiency in the Empower system, its features, and its administration, such as creating and managing projects, users, groups, privileges, instruments, methods, custom fields, etc.
- Experience in troubleshooting and resolving issues related to Empower, such as network, database, instrument, or software problems.
- Capable of working independently against deadlines in a fast-paced, and dynamic environment.
- High level of analytical, problem-solving, and decision-making skills.
- Excellent communication, collaboration, and leadership skills.
- Experience with MODA LIMS preferred.
- Advanced experience in project management and change management.
- Strong knowledge of computerized system validation
- Experience with ELN and implementation of paperless lab.