GMP Lab Equipment Specialist - Instrumentation & Validation

Tandem Project Management Ltd.

Tipperary

On-site

EUR 60,000 - 76,000

Full time

8 days ago

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Job summary

Tandem Project Management Ltd. is seeking a Laboratory Equipment Specialist for a pharmaceutical company based in Tipperary.

The role focuses on the installation and decommissioning of laboratory instruments, minimising downtime and ensuring compliance with validation, quality and safety requirements. The position supports drug substance and drug product instrumentation in clinical and commercial laboratory areas, coordinating with vendor engineers and ensuring documentation aligns with SDLC

Qualifications

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.

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.