LIMS Templator

Summary:
Our client, a biopharmaceutical company located in Dublin is looking for a LIMS Templator. The successful candidate will be responsible for supporting the data migration, LIMS templating and data entry efforts under the guidance and direction of the Business Workstream Lead and Project/Program Management.

Responsibilities:

• Work within the LIMS Modernization Project Team to provide laboratory business administration, implementation and technical support services for SM-LIMS, Biovia Smartlab (LMES) and Biovia CIMS (Inventory Management).
• Review of Quality Documentation e.g. Sample Plans, FORMs and Environmental Monitoring sample plans, Methods, Specifications to Build, develop and maintain LIMS templates.
• Evaluate new or revised LMES eProcedures in conjunction with SMEs.
• Provide support for LMES eProcedure revisions.
• Provide support for CIMS updates.
• Work with the Documentation Writers to provide support for SOP updates.
• Assist with developing and deliver training documents.
• Assist with UAT script writing.
• Be responsible for specific tasks within several workstreams associated to the LIMS Modernization Upgrade project.
• Ensure timely completion of each stage of the Project Tasks.
• Ensure flow of communication to stakeholders.

Qualifications & Experience:

• Hold a third level qualification in a Science related discipline.
• Minimum 4 years experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
• Familiar with (or can learn) new laboratory information systems and can self-teach technical topics.
• Familiar with system validation of computerized systems.
• Familiar with SQL querying, excel logic, java or html is a plus.
• Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.
• Knowledge on Data Integrity Assessments (DIA) for computerized systems and execution of CFR 21 Part 11 for computerized systems.
• Experience as a user (as a minimum) of LIMS System.
• Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information.