With a Pharmaceutical Company based in Swords, Dublin North.
This position is based at the R&D Centre in Swords, Co Dublin. The R&D Centre has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs).
The Analytical Instrumentation Specialist is responsible for providing support on the day-to-day running and maintenance of the equipment in the AR&D and R&D laboratories including managing and controlling the laboratory instrumentation qualification and unplanned maintenance programmes in the AR&D laboratories. In addition, the individual will be expected to contribute to the technical support of analytical methodology, development, transfer, qualification and troubleshooting pertaining to the manufacture of small molecule APIs and intermediates. The successful candidate will collaborate closely with other functions, including R&D Chemistry, Operations, Quality (QA/QC), SHE and external stakeholders/customers working towards the flawless, compliant and right first time manufacture of existing and new products.
Key responsibilities include:
- Carry out analytical testing in a timely manner for analytical method development, analytical testing, validation and qualification, where appropriate to ensure project deadlines are achieved.
- Liaise with QC Instrumentation personnel weekly to discuss the instrument qualification schedule and obtain a status of unplanned maintenance.
- Liaise with the IM and QA department on equipment projects as required.
- Manage the qualification program for all AR&D analytical instrumentation.
- Ensure equipment is maintained in a state of qualification and qualification activities or calibration checks have been completed and on time.
- Review all R&D laboratory Calibration/Qualification and Preventive Maintenance (PM) and equipment unplanned maintenance reports.
- Manage changes to R&D instruments, instrument relocations and decommissioning of R&D instruments.
- Manage the purchase of new instruments for R&D and related installation operation qualification reports that are required.
- Manage R&D laboratory instrument change controls.
- Ensure AR&D equipment and associated documentation is audit ready.
- Continually seek out opportunities to improve performance in the laboratory, reducing inefficiencies.
- Research and champion new technologies in the laboratory e.g. electronic data packages.
- Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.
- Ensure a safe work environment for oneself and all employees.
- Ensure high standards of housekeeping are maintained in the laboratory.
Required Key Skills and Experience include:
- Ideally a BSc/MSc in analytical chemistry or equivalent. Preferably a minimum of 3 to 5 years’ experience in analytical activities within a pharmaceutical manufacturing environment.
- Excellent core competencies such as teamwork, communication skills, technical writing skills.
- Strong technical background in chemistry, particularly analytical chemistry.
- Ability to work to tight timelines.
- Highly innovative and pro-active in driving change
- Good Troubleshooting skills.
- Openness to change, receptive to new ideas.
- Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations.