A medical device company in Centurion is seeking a Validations and Equipment Officer to join their team. The purpose of the role is to plan, execute and maintain installation, operational and performance qualification (IQ/OQ/PQ) of production and support equipment, ensure ongoing compliance of ISO 14644 cleanrooms, and manage calibration, maintenance and service schedules for all QC and production equipment across all group companies. Duties & Responsibilities Execute and maintain IQ, OQ and PQ of production and supporting equipment. Continuously monitor ISO 14644 cleanroom performance, environmental controls and escalation of deviations. Manage and maintain the group-wide equipment and calibration register. Ensure all QC, monitoring and production equipment is calibrated, within tolerance, and supported by valid certificates. Maintain preventive maintenance schedules, job cards, service histories and arrange service callouts. Provide hands-on technical support as a skilled technician/technologist across all companies in the group. Reporting the results and outcomes of validation activities. Manage the equipment list by ensuring the calibration activities of all Inspection, monitoring and testing equipment are completed on time and new equipment is added onto the list. Execute environmental monitoring activities according to the quality schedule. Arrange and send out Quarterly product testing samples to external testing labs. Perform periodic packaging verifications and Process simulations. Ensure all activities performed has been recorded and maintained according to specific company procedures and requirements. To participate in audits and inspections as required. Desired Experience & Qualification Tertiary degree required in natural sciences or engineering 2 years required minimum experience Good communication skills – writing, presentation and interpersonal communication High ethical standards Good understanding of statistics Computer literate: Microsoft Office Package & Remuneration R15 000 CTC pm (depending on experience and education)
Validations And Equipment Officer
PEOPLE DIMENSION
centurion, centurion
Published 4 days ago
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