Analytical Instrumentation Technician

This role involves planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.

• Responsible for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.
• Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.
• Responsible for the execution of protocols once approved.
• Candidate should have specific hands-on laboratory equipment lifecycle and validation experience.

• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & 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.
• 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.

• 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.

Candidates should possess excellent communication and problem-solving skills, be highly organized, and have the ability to work effectively in a team environment.

The ideal candidate will have hands-on experience with laboratory equipment and a strong understanding of cGMP regulations.

A background in science or engineering is highly desirable.

Please submit an updated CV for consideration.