LIMS Templator / LIMS Data Entry

Why you should apply:
 

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:
 

• Working 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:
    o Build, develop and maintain LIMS templates.
    o Evaluate new or revised LMES eProcedures in conjunction with SMEs.
    o Provide support for LMES eProcedure revisions
    o Provide support for CIMS updates
• Work with the Documentation Writers to:
  o Provide support for SOP updates.
  o Assist with developing and deliver training documents.
  o Assist with UAT script writing
• Be responsible for specific tasks within several workstreams associated to the LIMS Modernization Upgrade project.
  o Ensure timely completion of each stage of the Project Tasks
  o Ensure flow of communication to stakeholders.

• Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information.
• Excellent verbal and written communication skills including technical writing, presentation, and facilitation skills.
• Work collaboratively with global business team.
• Ability to work under minimal supervision.
• Ability to work in a fast-paced environment with changing priorities.
• Excellent Organizational and Time Management Skills.
• Ability to identify and manage competing priorities.
• Anticipate and prevent potential problems.
• Skills in the areas of teamwork, flexibility, coaching and motivating.
• 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