We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs.

This individual will be responsible for managing the routine maintenance and calibrations of analytical instrumentation across laboratories and manufacturing suites on site. This person will possess detail knowledge of process instrumentation including; application selection, developing specifications procurement of instruments and all aspects of their design and installation.

Duties:

• Oversee external vendors performing maintenance and calibrations in laboratories and manufacturing areas.
• Review and approval of data/documentation generated by external vendors.
• Work in collaboration with area owners, IT, and site services to ensure calibrations are completed on time, in compliance with up-to-date data integrity, regulatory, and industry standards.
• Perform routine entries in the local calibration maintenance software.
• Participate in deviations, CAPA’s and change control’s related to the maintenance of instruments in alignment with team priorities
• Provide support to maintain a state of permanent inspection readiness for regulatory and internal inspections and audits

• 3-5 years’ experience within the Biotech/Pharmaceutical industry.
• Level 7 or level 8 in Engineering, science, or related field and/or proven work experience as stated.
• Experience working in a GMP regulated environment.
• Experience and understanding of the change management requirements of validated systems and software.
• Experience with regulatory audits.