Senior Laboratory Equipment Specialist
We are seeking an experienced Senior Laboratory Equipment Specialist to join our team in a cGMP Quality Control environment. The successful candidate will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems.
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.
* 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 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 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 CMMA Maximo.
* Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
Requirements:
* 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, and 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 advantageous.