Job Title
Purpose:
Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities. Ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.
Main Responsibilities
1. Laboratory Equipment Maintenance: Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo.
2. Documentation and Review: Reviewing & filing of QC calibration & maintenance documentation.
3. New Equipment Qualification: 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.
4. Validation Life Cycle: Conduct periodic reviews of instrument validation as part of validation life cycle.
5. Equipment Repair and Maintenance: 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.
6. Technical Project Teams: Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
7. Data Integrity Assessments: 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.
Qualifications and Experience
* 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.
Key Skills
* Maximo
* Calibration
* Instrument Validation
* GMP