Summary:
A Laboratory Equipment Specialist is required for our client, a pharmaceutical company based in Tipperary. The successful candidate will manage the installation and decommissioning of laboratory instruments, minimising downtime and ensuring compliance with validation, quality and safety requirements. The role supports drug substance and drug product instrumentation in clinical and commercial laboratory areas.
Responsibilities:
- Manage the day-to-day installation and decommissioning of laboratory instruments and analytical equipment, using external support where required to meet operational targets.
- Ensure all equipment installation and decommissioning activities comply with current Good Manufacturing Practice (cGMP), and act as an auditee for this area.
- Ensure compliance with safety, environmental, trade compliance, human resources and spending requirements relevant to the role.
- Install instrumentation in accordance with laboratory validation policies, procedures and guidelines, and review and approve validation activities as required.
- Ensure instruments are released in a validated state and registered on the site equipment asset management system with appropriate preventive maintenance and periodic validation schedules.
- Troubleshoot installation issues and ensure associated investigations are raised, investigated and closed out appropriately.
- Coordinate on-site activities with vendor service engineers.
- Order and install new laboratory equipment, ensuring associated documentation complies with System Development Life Cycle requirements.
- Work independently as part of a team and contribute to departmental initiatives to improve compliance and quality systems.
Qualifications & Experience:
- BSc in Analytical Chemistry, Pharmaceutical Science or a related discipline, or an equivalent experience base.
- Knowledge of laboratory and site procedures, policies, guidelines and plant documentation.
- Understanding of laboratory testing, documentation, validation principles and System Development Life Cycle requirements.
- Computer proficiency and project management skills.
- Strong written and verbal communication, interpersonal and technical report writing skills.
- Effective time management, meeting management, planning and scheduling skills.
- Strong analytical and problem-solving skills.