Senior Pharmaceutical Microbiologist

Placements24; Randburg; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid leave

Hybrid work model

Job summary

Placements24 is seeking a Senior Pharmaceutical Microbiologist in Randburg, Gauteng. The role leads microbial testing, environmental monitoring and aseptic processing oversight to ensure product quality and safety in a hybrid work model.

The ideal candidate will have a Master’s or PhD in Microbiology with 5+ years in a regulated pharma setting, strong problem-solving, and excellent documentation skills. Join a dedicated QA team contributing to patient safety.

Qualifications

• Master's or PhD in Microbiology or related field.
• Minimum 5 years in pharmaceutical microbiology or a regulated environment.
• Proven expertise in microbial enumeration, sterility and endotoxin testing.
• Experience with environmental monitoring and aseptic processing.
• Knowledge of pharmacopoeias (USP, EP) and regulatory guidelines.

Responsibilities

• Lead microbial testing activities for raw materials, in-process and finished products.
• Develop, validate and transfer microbiological methods per pharmacopoeial/regulatory standards.
• Manage environmental monitoring programs for manufacturing areas and cleanrooms.
• Investigate OOS events, deviations, and root causes; implement corrective actions.
• Assess microbial risk for new products and manufacturing processes.
• Participate in facility and equipment qualification with microbiological focus.
• Prepare and review technical reports, protocols, and batch release docs.
• Train and mentor junior microbiologists and lab staff.
• Collaborate with QA, Manufacturing and R&D to address microbiological concerns.

Skills

Microbiology

Analytical skills

Problem-solving

Documentation

LIMS

Regulatory knowledge

Education

Master's or PhD in Microbiology

Tools

Office software

Sterility testing equipment

Job description

About the Role

Our client, a reputable pharmaceutical company, is seeking a skilled Senior Pharmaceutical Microbiologist to join their Quality Control department in Randburg, Gauteng . This role is essential for ensuring the microbial quality and safety of pharmaceutical products. The ideal candidate will have extensive experience in microbial testing, environmental monitoring, aseptic processing, and compliance with relevant pharmacopoeial standards and regulatory guidelines. You will be responsible for leading microbial testing activities, investigating deviations, and contributing to the overall quality assurance of the company's product portfolio. This position offers a rewarding opportunity to work within a dedicated team and contribute to public health through the production of safe and effective medicines, operating within a hybrid work model from Randburg, Gauteng .

Key Responsibilities

• Perform a variety of microbial tests on raw materials, in-process samples, finished products, and environmental samples.
• Develop, validate, and transfer microbiological methods according to pharmacopoeial and regulatory requirements.
• Conduct environmental monitoring programs for manufacturing areas, including cleanrooms and aseptic processing suites.
• Investigate microbial excursions, Out-of-Specification (OOS) results, and deviations, identifying root causes and implementing corrective actions.
• Assess the microbial risk associated with new products and manufacturing processes.
• Participate in facility and equipment qualification, with a focus on microbiological controls.
• Stay current with microbiological testing techniques, regulatory expectations, and industry best practices.
• Prepare and review technical reports, protocols, and batch release documentation.
• Train and mentor junior microbiologists and laboratory technicians.
• Collaborate with other departments, including Quality Assurance, Manufacturing, and R&D, to address microbiological concerns.

Requirements

• Master's degree or Ph.D. in Microbiology, Applied Microbiology, or a related biological science.
• A minimum of 5 years of experience in pharmaceutical microbiology or a related regulated industry.
• Proven expertise in microbial enumeration, identification, sterility testing, endotoxin testing, and microbial limits testing.
• Strong understanding of aseptic processing principles and cleanroom technology.
• Experience with method validation and environmental monitoring programs.
• Knowledge of relevant pharmacopoeias (e.g., USP, EP) and regulatory guidelines (e.g., FDA, EMA).
• Excellent analytical, problem-solving, and troubleshooting skills.
• Strong documentation and reporting abilities.
• Effective communication and interpersonal skills.
• Proficiency in working with laboratory information management systems (LIMS) and standard office software.
• Comfortable working in a hybrid model, requiring occasional on-site presence in Randburg, Gauteng .

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including health and wellness programs, retirement savings, and paid leave. Opportunities for professional growth and development are available. Employees will work in a modern laboratory setting and contribute to ensuring the highest standards of pharmaceutical quality and safety. This hybrid position offers flexibility, and the role is based in Randburg, Gauteng , providing a professional environment with the chance to impact patient well-being.