Job Title: Laboratory Systems Specialist
">
Our organization is seeking a skilled Laboratory Systems Specialist to plan, execute, and document the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.
">
* Manage and coordinate schedules with Calibration Technicians.
* Ensure all maintenance and calibration activities are tracked through the Computerised Maintenance Management System (CMMS).
* Author and own Validation Life Cycle documents for computer-related systems.
* Commission new laboratory equipment and facilities, including developing specifications.
* Write and approve validation protocols and summary reports.
* Conduct periodic reviews of instrument validation as part of the validation life cycle.
* Act as an expert on instrument validation regulations and procedures.
* Coordinate equipment repairs and maintenance with vendors/contractors.
* Write operating procedures and manuals.
* Design and conduct training for QC staff and other departments as applicable.
* Project manage Change controls and adhere to metrics.
* Provide updates on activities to senior management.
Requirements:
* Minimum 3 years laboratory experience in a cGMP environment, including analytical instrument validation.
* Knowledge of methodology and instrumentation used for biopharmaceutical testing.
* Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
* Demonstrated success in managing an equipment qualification or maintenance program.
Location: Dublin, Ireland