Senior QC Technical Services Specialist
Hybrid days role
RK5820
Contract 12 months initially
Dublin



We’re currently recruiting for an exciting opportunity with a leading healthcare organisation based in Dublin. This is an excellent position for an experienced Maintenance Technician looking to join a well-established organisation operating within the pharmaceutical and healthcare sector.


The Technical Services Specialist acts as a System Owner / Process Owner for the Technical Services Team. The Specialist is responsible for owning and delivering key quality, qualification and validation lifecycle documentation. The Specialist will support the Team manager in resource planning and resource support.

Operational responsibilities will include routine support on existing lab equipment to meet business needs, ensuring inspection readiness and oversight of all service activities carried out by Calibration Technicians. The systems are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.



Key Responsibilities:

• Planning and supervising routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
• Conduct periodic reviews and audit trail reviews of as part of validation life cycle of computerised lab equipment.
• Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
• Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
• Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
• Where applicable, owns and project manages change controls and adherence to Change Control metrics
• Supporting and managing the addition of project components to Maximo
• Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems
• Any other tasks/projects assigned as per manger’s request
• Responsible for authoring/owning, approving, executing all phases of Validation Life Cycle documents for computer related lab systems.
• Responsible for peer reviewing/approving colleague and cross functional teams Validation Life Cycle documents or associated auxiliary documentation relating to system guides or system configuration or vendor qualification/service documentation.
• Responsible for ensuring that all service activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo
• Support laboratory investigations, 5 why etc in event of equipment failure / performance issue during analytical analysis.

• Bachelor’s degree in a Science related field is required.
• Minimum of 5 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
• Detailed knowledge of pharmacopeia analytical methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity 21 CFR part 11.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.
• Experience across entire project lifecycle, planning phase, implementation phase and reporting phase.
• Experience of lab computerised system software applications as an elevated user or as a support function to lab during validation activities is an advantage.