Laboratory Systems IT Engineer

3 weeks ago

Newtown, Ireland Quanta Consultancy Services Ltd Full time
Job Title: Laboratory Systems IT Engineer - PharmaceuticalsContract Duration: 12 Months

We are seeking a skilled Laboratory Systems IT Engineer to join our client's team, a leading pharmaceutical organisation in Ireland. As a key member of their newly assembled team, you will contribute towards the development of their next core projects.

Key Responsibilities:
  1. Lab Equipment Ownership and Administration: Oversee the IS aspects of Lab equipment, including analytical equipment platform architecture, system ownership, and lifecycle management.
  2. Project Management and Communication: Provide effective communication and lead project management interactions with internal and external clients, such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
  3. System Improvements and Development: Lead and support system improvements, develop detailed specifications, and standard operating procedures.
  4. Laboratory Equipment Instrumentation: Ensure reliable, consistent, and compliant operation of Lab Equipment Instruments to meet GMP and business requirements.
  5. Troubleshooting and Root Cause Analysis: Lead technical root cause analysis, incident investigations, and troubleshooting issues related to Quality and Laboratory information systems.
  6. Change Control and Validation Practices: Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
  7. Computer Software Validations: Participate in Computer Software Validations and protocol/script writing.
  8. IS Assessments and System Configuration Changes: Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
Requirements:
  • LIMS and Empower Experience: Desirable experience with LIMS and Empower.
  • Regulatory Knowledge: Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.
  • Regulatory Audits: Desirable experience with regulatory/customer audits.
  • Quality and Laboratory Information Systems Experience: At least 3 years' experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and gained expertise in Laboratory information systems.
  • Empower CDS, Sample Manager LIMS, and Analytical Equipment Experience: Advantageous experience with Empower CDS, Sample Manager LIMS, Laboratory Analytical Equipment, and instruments.
Education and Skills:
  • Working Knowledge of GAMP Software Development Lifecycle: Must have a working knowledge of the GAMP software development lifecycle.
  • Facility Start-up Projects and Training Experience: Desirable experience with facility start-up projects (brown field or green field) and training personnel.
  • Microsoft Office Suite and Project Management: Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project is required.
  • Databases, Reporting, and Analytics Systems: Strong knowledge of databases, reporting, and analytic systems.

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