Job Summary:
The Biotech Quality Specialist will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.
* Ensure all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through a Computerised Maintenance Management System (CMMS).
* Author and approve Validation Life Cycle documents for computer related systems, including Data Integrity testing and business administration of Laboratory Computer Related systems.
* Execute approved protocols.
* Plan and conduct routine calibration, requalification and maintenance of laboratory equipment ensuring schedules are adhered to as per CMMS.
* Review and file QC calibration & maintenance documentation.
* Plan, execute and document the qualification of 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 validation life cycle.
* Alert Quality Control Management in the event of 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, 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.
* Own and project manage change controls and adherence to Change Control metrics where applicable.
* Support and manage the addition of project components to CMMS.
* 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.
* Candidates should have hands-on laboratory equipment lifecycle and validation experience.
* Candidates should have direct involvement in equipment quality installation or maintenance programs beyond simple data entry or using spreadsheets.
* A thorough document review related to maintenance activities is a key aspect of this role.
* Ideal candidates have a proven track record of assessing equipment integrity through periodic validation and challenge testing, ensuring ongoing compliance.
* Experience in computer system validation (CSV) or equivalent is highly valued.
* Strong familiarity with relevant computer applications is essential, enabling efficient management of documentation, reporting, and data analysis tasks.
* Demonstrated experience in change control processes is critical.
* Candidates should be able to manage and document changes to equipment, procedures, or systems while ensuring regulatory compliance and operational continuity.
* 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.
* Demonstrated success in managing an equipment qualification or maintenance program is advantageous.