Senior QC Technical Services Specialist

Life Science Recruitment; Leinster; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment is seeking a Technical Services Specialist for a leading healthcare organisation in Dublin. The role acts as System Owner/Process Owner for the Technical Services Team and is responsible for owning and delivering key quality, qualification and validation lifecycle documentation, while supporting resource planning.

Responsibilities include routine calibration/maintenance in a cGMP environment, writing validation protocols and reports, CMMS Maximo management, change

Qualifications

• Bachelor's degree in science or related field.
• 5+ years laboratory experience in a cGMP setting.
• Experience with analytical instrument validation and data integrity.

Responsibilities

• Plan and supervise calibration, requalification and maintenance of lab equipment per CMMS Maximo.
• Draft and review qualification protocols and summary reports for new equipment.
• Conduct audit trail reviews as part of validation lifecycle for computerised lab equipment.
• Coordinate equipment repairs with vendors, minimise downtime.
• Act as SME on instrument validation regulations and procedures.
• Own change controls and project components in Maximo.
• Support Data Integrity Assessments for lab systems.
• Peer-review validation documents and system guides.

Skills

Laboratory maintenance

Documentation & validation

Regulatory compliance

Project coordination

Education

Bachelor's degree in Science

Tools

CMMS Maximo

Change Control

Job description

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.

Education and Experience:

• 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.