Steriliser Qualification Microbiologist

MAIN TASKS / RESPONSIBILITIES: Steam Sterilisation Qualification & Validation

• Plan and execute routine and non-routine steriliser qualification studies in accordance with SOP 20-04-02-062.
• Generate random probing patterns and perform thermal mapping of sterilisation cycles.
• Ensure correct placement of thermocouples and biological indicators in sterilisation cycles.
• Conduct closure validation studies for liquid products as per SOP 12-02-17-017.
• Perform volume displacement studies where applicable for large-volume parenteral LVP products.
• Ensure compliance with sterilisation protocols and acceptance criteria.
• Maintain accurate records of sterilisation status, qualification schedules, and expiry dates.

Documentation & Compliance

• Review and approve sterilisation qualification studies and validation protocols.
• Ensure all sterilisation documentation meets GMP, ISO 13485, and regulatory requirements.
• Maintain qualification status reports, ensuring all data is accurately logged and accessible.
• Ensure all sterilisation qualification packages are completed and filed per SOP requirements.
• Initiate and track Hold Notices for non-compliant sterilisation cycles.

Equipment Calibration & Maintenance

• Conduct routine calibration of temperature probes, data loggers, and validation equipment per SOP 20-04-02-036.
• Ensure that sterilisation qualification equipment is in good working condition and is stored appropriately.

Audits & Investigations

• Participate in internal and external audits related to sterilisation and microbiology.
• Support the investigation of sterilisation failures, deviations, and CAPAs Corrective and Preventive Actions.
• Assist in responding to regulatory inspections and prepare necessary documentation.

Project & Process Improvement Activities

• Provide input for sterilisation-related change controls and validation projects.
• Work closely with Engineering, Production, and Quality Assurance to optimise sterilisation processes.
• Implement new technologies and best practices in sterilisation microbiology.

Training & Development

• Train junior microbiologists and operators on sterilisation qualification procedures.
• Ensure all staff follow best practices for contamination control, sterility assurance, and GMP compliance.

SPECIAL KNOWLEDGE, SKILLS AND DUTIES: Technical Knowledge & Skills

• Strong understanding of microbiology, sterilisation science, and validation principles.
• Expertise in thermal mapping, biological indicators, and sterility assurance levels SALs.
• Experience with root cause analysis and corrective actions for sterilisation failures.
• Proficient in data analysis, statistical evaluation, and report writing.
• Working knowledge of ISO 13485, GMP, and pharmacopoeial guidelines.
• Familiarity with sterility testing, endotoxin testing, and environmental monitoring.

Regulatory & Compliance Skills

• Strong knowledge of SAHPRA, ISO 13485 regulations.
• Experience in preparing for and supporting regulatory audits and inspections.
• Ability to interpret and apply pharmacopoeial standards USP, BP, EP.

Problem-Solving & Decision-Making

• Ability to identify non-conformances in sterilisation processes and recommend corrective actions.
• Make critical decisions regarding sterilisation cycle acceptability and qualification validity.
• Strong analytical and troubleshooting skills to resolve sterilisation deviations.

Pharmacovigilance Principles

• Understanding of pharmacovigilance practices for monitoring and reporting adverse events.
• Commitment to contributing to pharmacovigilance efforts.

ISO 13485 Standards

• Basic awareness of ISO 13485 standards for quality management systems.
• Recognition of the importance of quality management systems in ensuring product safety and compliance.

Requirements

Qualifications

• Bachelor of Science BSc Degree with a Major in Microbiology OR National Diploma in Microbiology / Biotechnology Experience
• Minimum 3–5 years experience in a pharmaceutical, biotechnology, or sterile manufacturing environment.
• Experience in sterilisation validation, autoclave qualification, and microbiological quality assurance.
• Knowledge of GMP Good Manufacturing Practice, ISO 13485, and Pharmacopoeial standards USP, EP, BP.
• Experience with steam sterilisation validation, thermal mapping, and biological indicators.
• Familiarity with regulatory compliance requirements
• Hands-on experience with calibration, environmental monitoring, and media preparation.
• Strong documentation skills, including SOP writing, protocol review, and validation reports.
• Computer literacy in LIMS, Microsoft Office Excel, Word, PowerPoint, and data analysis software.

Languages English Other

• Ability to work in a cleanroom/sterile manufacturing environment while adhering to gowning and contamination control protocols.
• Strong understanding of microbiological principles, steam sterilisation, and thermal validation processes.
• Ability to handle and interpret biological indicator BI results.
• Capability to troubleshoot sterilisation deviations and recommend corrective actions.
• Strong analytical and problem-solving skills for qualification failures.
• Must be able to work independently and in a team, ensuring adherence to strict deadlines.