Steriliser Qualification Microbiologist

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JOB PURPOSE:The Steriliser Qualification Microbiologist ensures that all sterilisation processes meet industry, regulatory, and company standards through thorough validation and qualification studies. The role includes performing and reviewing sterilisation studies, maintaining qualification documentation, and supporting audits, projects, and continuous improvement initiatives. 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.

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.