The purpose of this role is:

Provide technical support to the Laboratory departments at EirGen Pharma by maintaining all laboratory instrumentation in an operational & qualified state. This role will ensure that both instrument hardware and software qualifications are completed in a timely manner.

This role will report within the R&D Group to the Analytical Cleaning Validation Manager

This role includes, but is not limited to activities in the following areas:

  • Introduction, set up and commissioning of new instrumentation.
  • Maintenance and calibration of existing instrumentation.
  • Administration and maintenance of Laboratory instrumentation software systems excluding Empower.

Responsibilities include:

  • Develop, maintain and execute all instrumentation calibration & maintenance schedules ensuring that all stake holders are kept informed where required.
  • Perform all necessary internal instrument calibrations & maintenance, for example monthly calibration of balances, UV, FT-IR, etc.
  • Organise & manage the identification, evaluation, purchasing, installation & qualification of any new laboratory instrumentation along with all relevant documentation.
  • Organise, supervise and approve all external maintenance & calibrations carried out by external vendors on Laboratory instrumentation.
  • Develop & write all necessary SOP’s & validation protocols relating to the operation, qualification and maintenance of all laboratory instrumentation as necessary.
  • Develop a working knowledge of all instrumentation software platforms and troubleshoot them as necessary.
  • Perform/participate in instrument/method trouble shooting as required.
  • Represent the Instrumentation Laboratory function at all project meetings both internal and external as required, feeding back status updates to the group when necessary.
  • Ensure all work is carried out in compliance with the required standards, conforming to company, cGxP, SOPs and regulatory regulations and guidelines.
  • Produce and maintain accurate, GMP compliant records.
  • Identify & make recommendations for improvements within or outside the department in order to ensure the continuous improvement of the company.

Health and Safety

  • Ensure requirements of EirGen’s Safety Statement are implemented.
  • Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  • Report any instrument defects or site hazards.
  • Continuously promote a positive safety culture by leading by example.

The ideal candidate for this role will have the following:

  • BSc in Chemistry or related discipline; may consider another qualification with relevant experience.
  • 3 – 5 years relevant experience in a cGMP environment is required
  • Experience in any of the following would be considered advantageous:
  • Prior experience in maintenance, qualification and calibration of laboratory instrumentation.
  • Prior experience in laboratory software administration.
  • Working knowledge of change controls and risk assessments.
  • Prior experience in project management.