Senior Laboratory Equipment Validation Specialist
2 weeks ago
Our organization is seeking a skilled Quality Control Specialist to perform qualification, calibration and routine maintenance of laboratory systems in a cGMP environment.
Key Responsibilities:- Plan and execute the validation of laboratory equipment to ensure compliance with regulatory requirements.
- Oversee tracking and management of activities through a Computerized Maintenance Management System (CMMS).
- Authorise and approve validation life cycle documents for computer-related systems.
- Ensure data integrity compliance throughout the lifecycle of laboratory equipment.
- Execute approved protocols to validate laboratory equipment.
- Conduct routine calibration, requalification and maintenance of laboratory equipment ensuring schedules are adhered to as per CMMS.
- Review and file quality control calibration and maintenance documentation.
- Qualify new laboratory equipment in a cGMP regulated environment, including writing of equipment validation protocols and associated summary reports.
- Conduct periodic reviews of instrument validation as part of the validation life cycle.
- Alert management to any equipment failing to meet calibration or qualification requirements and conduct impact assessments/investigations as required.
- Schedule and coordinate equipment repairs and maintenance with vendors/contractors while minimizing downtime for lab equipment and disruption to laboratory activities.
- Participate in technical project teams as a subject matter expert on instrument validation regulations and procedures.
- Manage change controls and adherence to Change Control metrics where applicable.
- Support and manage the addition of project components to CMMS Maximo.
- Act as a key contributor 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 methodology, instrumentation and analytical techniques used for biopharmaceutical testing.
- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
- Previous success in managing an equipment qualification or maintenance program is advantageous.
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