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.
- 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.