13628 – Laboratory Instrument Specialist – Tipperary Contractor

Purpose:

This is a 10 month contract position.

The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site.  This involves testing of raw materials, Excipients, Components, intermediates, Drug Substance and Drug product. We are currently recruiting for the position of Instrument/Validation Specialist in support of these activities. The position reports to the Laboratory Systems Lead.

Responsibilities:

• Maintaining Analytical Laboratory instrumentation in validated state to support testing activities in accordance with site schedules and company policies, procedures, and guidelines.
• The Instrumentation Specialist will lead troubleshooting activities and use external support as required to meet customer targets.
• Provides a preventative maintenance service to ensure functionality and a calibration service to maintain the instruments according to their working specifications.
• Ensures that all instruments are maintained in a validated state through a PM/PV schedule and ensuring that this schedule is adhered to by the Instrument group and contract vendors.
• Support the introduction of new technology and instrumentation to the site with a focus on Data Integrity principles.
• Responsible for the decommissioning of all equipment as appropriate.
• Be part of a dynamic team responsible for Data Integrity requirements for all computerised and non-computerised systems across all the laboratories.
• Aid in the resolution of issues that may arise during laboratory instrument qualification and use.
• Participate in assigned improvement projects.