Validations and Equipment Officer

SUMMARY:
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POSITION INFO:

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)