Manager Lab IT

2 weeks ago

Petersburg, United States Global Recruiters of Dublin (GRN Dublin) Full time

Essential Duties and Responsibilities:

  • Identify and drive computerized system innovation and improvement opportunities, leveraging new technologies and methodologies.
  • Drive the selection, installation, testing, maintenance, training, and support of laboratory systems.
  • Manage the budget for IT Laboratory Systems, resources, and vendors, ensuring the optimal utilization and allocation of the system assets and services.
  • 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 compliance, accuracy, completeness, consistency, and availability in alignment with industry standards.
  • Manage existing LIMS, CDS, and Empower systems responsibilities including projects, users, groups, privileges, instruments, methods, custom fields, and troubleshooting/resolving issues.
  • Coordinate with vendors and ensure the proper configuration, upgrade, backup, and recovery of the laboratory systems.
  • Manage the integration, validation, and maintenance of stand-alone lab instruments and ensure their compatibility and connectivity with laboratory systems and data.
  • Monitor and report on the computerized system performance, risks, and issues, and implement corrective and preventive actions as needed.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Excellent communication, collaboration, and leadership skills.
  • 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, and the ability to troubleshoot and resolve database, instrument, and software issues.
  • A familiarity with the stand-alone lab instruments, their functions, and their requirements.
  • 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.
  • Capable of working independently against deadlines in a fast-paced, and dynamic environment.
  • High level of analytical, problem-solving, and decision-making skills.

Preferred Qualifications:

  • Experience with MODA LIMS & Empower preferred.
  • Advanced experience in project management and change management.
  • Strong knowledge of computerized system validation
  • Experience with ELN and implementation of paperless labs.

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