Senior Laboratory Equipment Specialist
4 days ago
We are seeking a highly skilled Senior Laboratory Specialist to join our team. As a key member of the Quality Control laboratory, you will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems.
The ideal candidate should have direct involvement in equipment quality installation or maintenance programs, with a proven track record of assessing equipment integrity through periodic validation and challenge testing.
Key Responsibilities:- Planning and conducting routine calibration, requalification, and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo.
- Reviewing and filing of QC calibration and 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.
- Conducting periodic reviews of instrument validation as part of validation life cycle.
- 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 downtime 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, owning and project managing change controls and adherence to Change Control metrics.
- Supporting and managing the addition of project components to CMMA Maximo.
- Acting as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
- Bachelor's degree in a Science-related field is required.
- Minimum of 3 years of laboratory experience in a cGMP laboratory environment, including exposure to analytical instrument validation and data integrity assessments.
- Detailed knowledge of the methodology, instrumentation, and analytical techniques 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 is advantageous.
This role offers a challenging and rewarding opportunity for professional growth and development in a dynamic laboratory environment.
You will have the opportunity to work with a talented team of professionals who share your passion for excellence and commitment to quality.
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