Steriliser Qualification Microbiologist

In brief

**Overview** This role is for a Steriliser Qualification Microbiologist at Adcock Ingram. The position is responsible for ensuring the sterility and safety of products through the planning, execution, and documentation of sterilisation qualification and validation studies, maintaining compliance with regulatory standards, and contributing to process improvement and training within a pharmaceutical or biotechnology environment. **What you will do** Key responsibilities include: * **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. **Requirements (from the original advert)** * **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. **Who should apply** The ideal candidate will possess a strong understanding of microbiology, sterilisation science, and validation principles, with expertise in thermal mapping, biological indicators, and sterility assurance levels (SALs). They should have experience with root cause analysis and corrective actions for sterilisation failures, be proficient in data analysis, statistical evaluation, and report writing, and have working knowledge of ISO 13485, GMP, and pharmacopoeial guidelines. Familiarity with sterility testing, endotoxin testing, and environmental monitoring is also expected. The candidate should demonstrate strong knowledge of SAHPRA and ISO 13485 regulations, with experience in preparing for and supporting regulatory audits and inspections, and the ability to interpret and apply pharmacopoeial standards (USP, BP, EP). Critical problem-solving and decision-making skills are essential, including the ability to identify non-conformances in sterilisation processes, recommend corrective actions, and make decisions regarding sterilisation cycle acceptability and qualification validity. A strong commitment to pharmacovigilance efforts and a basic awareness of ISO 13485 standards for quality management systems are also important. **Deadline** Not specified **Reference** Original posting: https://www.myjobmag.co.za/job/steriliser-qualification-microbiologist-adcock-ingram Source: myjobmag

Summary drafted with AI assistance from the original advert. The advert itself is the authority — how we use AI.

At a glance

• At least 3 years of experience.

• Microsoft Excel
• Microsoft Office

Extracted automatically from the advert; confirm requirements on the original listing.

Job description

Before you apply

• Confirm the requirements and closing date on the original listing (myjobmag). SPANi lists vacancies from other sites and may not reflect last-minute changes.
• Legitimate employers do not charge application, registration or training fees.
• Don't send your ID or bank details before you have confirmed the employer is real.

How to spot a job scam

Before you apply

• Read the full advert and confirm you meet the minimum requirements before applying.
• Tailor your CV headline and most recent experience to the job title and key skills.
• Note the closing date and reference number, and keep a copy of what you submit.
• Apply only through the employer or job board link — never pay to apply.