Job Description
The partnership with a leading Contract Development and Manufacturing organisation is seeking an Instrumentation Specialist to join their team on a 12-month contract at their Swords Campus in North Dublin.
About the Organisation
The organisation is a global leader in the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years.
Current Need
The Instrumentation department are seeking to recruit an Instrumentation Specialist for a 12 months contract position. This position is in the group in the Instrumentation Department.
Position Description
Reporting to the Team Lead, the successful candidate will manage and control the laboratory instrumentation calibration and unplanned maintenance programme for the department. The role involves:
* Liaising with suppliers to coordinate the calibration schedule.
* Reviewing all Laboratory Calibration/Qualification documentation.
* Reviewing all equipment unplanned maintenance reports.
* Managing changes to instruments, instrument relocations, and decommissioning of instruments.
* Troubleshooting laboratory equipment.
* Managing the purchase of new instruments and related installation operation qualification reports.
* Managing laboratory instrument change controls.
* Developing new procedures and ensuring equipment procedures are up to date.
* Conducting all instrumentation calibration investigations.
* Supporting the implementation and qualification of analytical instruments, and in their routine/periodic maintenance.
* Ensuring Compliance of laboratory operations and documentation.
* Managing supplier relations for new equipment and software to be used in the laboratory.
* Fostering and supporting a culture of growth, enablement, and high performance.
Requirements
A degree in Analytical Science, Chemistry, or a related discipline is required. A minimum of 3 years' experience working in the industry is required.
Knowledge of Quality Control operations.
Experience of regulatory agency audits and an understanding of laboratory GMP's regulations and their application to API manufacturing.
Experience in Equipment Validation and the change control procedures is desirable.
The successful candidate will have a strong ability to manage their own workload, prioritise work, and ensure timelines are met for equipment calibrations, maintenance, and testing.